Trial Outcomes & Findings for Trametinib and Docetaxel in Treating Patients With Recurrent or Stage IV KRAS Mutation Positive Non-small Cell Lung Cancer (NCT NCT02642042)

NCT ID: NCT02642042

Last Updated: 2025-11-10

Results Overview

Proportion of participants who have a partial or complete response to treatment per RECIST v1.1 Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 60 participants
• Primary outcome timeframe: Up to 3 years
• Results posted on: 2025-11-10

Participant Flow

60 participants were enrolled. However, 4 were found to be ineligible and 2 did not receive protocol treatment and so were not analyzable. Thus only 54 were included in the analysis.

Participant milestones

Measure	Treatment (Trametinib, Docetaxel) Participants receive trametinib PO on days 1-21. Participants also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Trametinib: Given PO
Overall Study STARTED	54
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	54

Reasons for withdrawal

Measure	Treatment (Trametinib, Docetaxel) Participants receive trametinib PO on days 1-21. Participants also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Trametinib: Given PO
Overall Study Adverse Event	22
Overall Study Refusal Unrelated to Adverse Event	1
Overall Study Progression/Relapse	28
Overall Study Death	1
Overall Study Not Protocol Specified	2

Baseline Characteristics

Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).

Baseline characteristics by cohort

Measure	Treatment (Trametinib, Docetaxel) n=54 Participants Participants receive trametinib PO on days 1-21. Participants also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Trametinib: Given PO
Age, Continuous All Participants	65 years n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Age, Continuous Participants with G12C Mutation	66 years n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Age, Continuous Participants with Non-G12C Mutation	63 years n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Sex: Female, Male All Participants · Female	31 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Sex: Female, Male All Participants · Male	23 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Sex: Female, Male Participants with G12C Mutation · Female	11 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Sex: Female, Male Participants with G12C Mutation · Male	8 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Sex: Female, Male Participants with Non-G12C Mutation · Female	20 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Sex: Female, Male Participants with Non-G12C Mutation · Male	15 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=54 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=54 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=54 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=54 Participants
Race (NIH/OMB) Asian	2 Participants n=54 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=54 Participants
Race (NIH/OMB) Black or African American	5 Participants n=54 Participants
Race (NIH/OMB) White	46 Participants n=54 Participants
Race (NIH/OMB) More than one race	0 Participants n=54 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=54 Participants
Smoking Status All Participants · Current	12 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Smoking Status All Participants · Former	38 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Smoking Status All Participants · Never	4 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Smoking Status Participants with G12C Mutation · Current	2 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Smoking Status Participants with G12C Mutation · Former	15 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Smoking Status Participants with G12C Mutation · Never	2 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Smoking Status Participants with Non-G12C Mutation · Current	10 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Smoking Status Participants with Non-G12C Mutation · Former	23 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Smoking Status Participants with Non-G12C Mutation · Never	2 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Zubrod Performance Status All Participants · 0	16 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Zubrod Performance Status All Participants · 1	37 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Zubrod Performance Status All Participants · 2	1 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Zubrod Performance Status Participants with G12C Mutation · 0	6 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Zubrod Performance Status Participants with G12C Mutation · 1	12 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Zubrod Performance Status Participants with G12C Mutation · 2	1 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Zubrod Performance Status Participants with Non-G12C Mutation · 0	10 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Zubrod Performance Status Participants with Non-G12C Mutation · 1	25 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Zubrod Performance Status Participants with Non-G12C Mutation · 2	0 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Histology All Participants · Adenocarcinoma	48 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Histology All Participants · Other	6 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Histology Participants with G12C Mutation · Adenocarcinoma	17 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Histology Participants with G12C Mutation · Other	2 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Histology Participants with Non-G12C Mutation · Adenocarcinoma	31 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Histology Participants with Non-G12C Mutation · Other	4 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Metastic Sites at Baseline (Liver) All Participants	17 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Metastic Sites at Baseline (Liver) Participants with G12C Mutation	8 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Metastic Sites at Baseline (Liver) Participants with Non-G12C Mutation	9 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Metastic Sites at Baseline (Brain) All Participants	7 Participants n=54 Participants • Measure Analysis Population Description: Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Metastic Sites at Baseline (Brain) Participants with G12C Mutation	4 Participants n=19 Participants • Measure Analysis Population Description: Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Metastic Sites at Baseline (Brain) Participants with Non-G12C Mutation	3 Participants n=35 Participants • Measure Analysis Population Description: Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Prior Regimens All Participants · 1	16 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Prior Regimens All Participants · 2	38 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Prior Regimens Participants with G12C Mutation · 1	6 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Prior Regimens Participants with G12C Mutation · 2	13 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Prior Regimens Participants with Non-G12C Mutation · 1	10 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Prior Regimens Participants with Non-G12C Mutation · 2	25 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Prior Immunotherapy All Participants · Yes	31 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Prior Immunotherapy All Participants · No	23 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Prior Immunotherapy Participants with G12C Mutation · Yes	12 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Prior Immunotherapy Participants with G12C Mutation · No	7 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Prior Immunotherapy Participants with Non-G12C Mutation · Yes	19 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
Prior Immunotherapy Participants with Non-G12C Mutation · No	16 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type All Participants · G12A	9 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type All Participants · G12C	19 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type All Participants · G12D	9 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type All Participants · G12F	1 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type All Participants · G12S	2 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type All Participants · G12V	7 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type All Participants · G13C	4 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type All Participants · G13D	1 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type All Participants · Q61K	1 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type All Participants · Q61L	1 Participants n=54 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type Participants with G12C Mutation · G12A	0 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type Participants with G12C Mutation · G12C	19 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type Participants with G12C Mutation · G12D	0 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type Participants with G12C Mutation · G12F	0 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type Participants with G12C Mutation · G12S	0 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type Participants with G12C Mutation · G12V	0 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type Participants with G12C Mutation · G13C	0 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type Participants with G12C Mutation · G13D	0 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type Participants with G12C Mutation · Q61K	0 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type Participants with G12C Mutation · Q61L	0 Participants n=19 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type Participants with Non-G12C Mutation · G12A	9 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type Participants with Non-G12C Mutation · G12C	0 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type Participants with Non-G12C Mutation · G12D	9 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type Participants with Non-G12C Mutation · G12F	1 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type Participants with Non-G12C Mutation · G12S	2 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type Participants with Non-G12C Mutation · G12V	7 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type Participants with Non-G12C Mutation · G13C	4 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type Participants with Non-G12C Mutation · G13D	1 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type Participants with Non-G12C Mutation · Q61K	1 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).
KRAS Mutation Type Participants with Non-G12C Mutation · Q61L	1 Participants n=35 Participants • Eligible and analyzable participants were stratified based on whether they had G12C mutation or non-G12C mutations. Baseline measures are reported in separate rows for all participants (54), participants with G12C mutation (19), and participants with non-G12C mutations (35).

PRIMARY outcome

Timeframe: Up to 3 years

Population: All eligible and analyzable participants

Proportion of participants who have a partial or complete response to treatment per RECIST v1.1

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Measure	Treatment (Trametinib, Docetaxel) n=54 Participants Participants receive trametinib PO on days 1-21. Participants also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Trametinib: Given PO
Response Rate (Confirmed and Unconfirmed Complete and Partial Responses) in All KRAS Mutant Participants	0.33 proportion of participants Interval 0.21 to 0.47

SECONDARY outcome

Timeframe: Up to 3 years

Population: Eligible and analyzable participants with G12C KRAS mutation

Proportion of participants who have a partial or complete response to treatment per RECIST v1.1

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Measure	Treatment (Trametinib, Docetaxel) n=19 Participants Participants receive trametinib PO on days 1-21. Participants also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Trametinib: Given PO
Response Rate (Confirmed and Unconfirmed Complete and Partial Responses) in Participants With G12C KRAS Mutation	0.26 proportion of participants Interval 0.09 to 0.51

SECONDARY outcome

Timeframe: up to 3 years

Population: Eligible and analyzable participants with Non-G12C mutation

Proportion of participants who have a partial or complete response to treatment per RECIST v1.1

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Measure	Treatment (Trametinib, Docetaxel) n=35 Participants Participants receive trametinib PO on days 1-21. Participants also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Trametinib: Given PO
Response Rate (Confirmed and Unconfirmed Complete and Partial Responses) in Participants With Non-G12C KRAS Mutation	0.37 proportion of participants Interval 0.21 to 0.55

SECONDARY outcome

Timeframe: Up to 3 years

Population: All eligible and analyzable participants

Time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed using the same techniques as baseline, as well as absolute increase of at least 0.5 cm; unequivocal progression of non-measurable disease; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration.

Outcome measures

Measure	Treatment (Trametinib, Docetaxel) n=54 Participants Participants receive trametinib PO on days 1-21. Participants also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Trametinib: Given PO
Progression Free Survival in All KRAS Mutant Participants	4.1 months Interval 3.1 to 5.1

SECONDARY outcome

Timeframe: Up to 3 years

Population: Eligible and analyzable participants with G12C KRAS mutation

Time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed using the same techniques as baseline, as well as absolute increase of at least 0.5 cm; unequivocal progression of non-measurable disease; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration.

Outcome measures

Measure	Treatment (Trametinib, Docetaxel) n=19 Participants Participants receive trametinib PO on days 1-21. Participants also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Trametinib: Given PO
Progression Free Survival in Participants With G12C KRAS Mutation	3.3 months Interval 1.5 to 4.3

SECONDARY outcome

Timeframe: Up to 3 years

Population: Eligible and analyzable participants with non-G12C KRAS mutation

Time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed using the same techniques as baseline, as well as absolute increase of at least 0.5 cm; unequivocal progression of non-measurable disease; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration.

Outcome measures

Measure	Treatment (Trametinib, Docetaxel) n=35 Participants Participants receive trametinib PO on days 1-21. Participants also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Trametinib: Given PO
Progression Free Survival in Participants With Non-G12C KRAS Mutation	4.1 months Interval 3.4 to 5.6

SECONDARY outcome

Timeframe: Up to 3 years

Population: All eligible and analyzable participants

Time from date of registration to date of death due to any cause.

Outcome measures

Measure	Treatment (Trametinib, Docetaxel) n=54 Participants Participants receive trametinib PO on days 1-21. Participants also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Trametinib: Given PO
Overall Survival in All KRAS Mutants	10.9 months Interval 8.0 to 14.0

SECONDARY outcome

Timeframe: Up to 3 years

Population: Eligible and analyzable participants with G12C KRAS mutation

Time from date of registration to date of death due to any cause.

Outcome measures

Measure	Treatment (Trametinib, Docetaxel) n=19 Participants Participants receive trametinib PO on days 1-21. Participants also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Trametinib: Given PO
Overall Survival in Participants With G12C KRAS Mutation	8.8 months Interval 4.9 to 10.9

SECONDARY outcome

Timeframe: up to 3 years

Population: Eligible and analyzable participants with non-G12C KRAS mutation

Time from date of registration to date of death due to any cause.

Outcome measures

Measure	Treatment (Trametinib, Docetaxel) n=35 Participants Participants receive trametinib PO on days 1-21. Participants also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Trametinib: Given PO
Overall Survival in Participants With Non-G12C KRAS Mutation	12.2 months Interval 8.0 to 18.8

SECONDARY outcome

Timeframe: Duration of treatment and follow up until death or 3 years post registration

Population: Patients who received at least one dose of protocol treatment.

Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Outcome measures

Measure	Treatment (Trametinib, Docetaxel) n=54 Participants Participants receive trametinib PO on days 1-21. Participants also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Trametinib: Given PO
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypotension	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypoxia	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Left ventricular systolic dysfunction	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Lung infection	5 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Lymphocyte count decreased	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Mucositis oral	4 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Multi-organ failure	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Myocardial infarction	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Nausea	3 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Neutrophil count decreased	4 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Palmar-plantar erythrodysesthesia syndrome	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pericardial effusion	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Peripheral sensory neuropathy	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pneumonitis	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pruritus	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Rash acneiform	3 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Rash maculo-papular	8 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Rash pustular	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Respiratory failure	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Restrictive cardiomyopathy	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Sepsis	6 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Stroke	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Thromboembolic event	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Upper gastrointestinal hemorrhage	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Urinary tract infection	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Vomiting	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs White blood cell decreased	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Wound infection	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Abdominal pain	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Alanine aminotransferase increased	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Anemia	4 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Anorexia	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Aspartate aminotransferase increased	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Colitis	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Conjunctivitis	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dehydration	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Diarrhea	5 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dyspnea	4 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Ejection fraction decreased	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Electrocardiogram QT corrected interval prolonged	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Fatigue	8 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Febrile neutropenia	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Gastrointestinal disorders - Other, specify	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Generalized muscle weakness	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hyperkalemia	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypermagnesemia	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypokalemia	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hyponatremia	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

The response rate between patients with dysfunctional p53 will be compared to the response rate in patients without p53 dysfunction.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

The response rate between patients with LKB1 disruption will be compared to the response rate in patients without LKB1 disruption. The response rate will be estimated by LKB1 disruption status (yes/no), along with 95% confidence intervals around the estimated proportions. This analysis will evaluate if disruption in LKB1 is associated with a lower probability of response.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Trametinib, Docetaxel)

Serious events: 31 serious events

Other events: 54 other events

Deaths: 44 deaths

Serious adverse events

Measure	Treatment (Trametinib, Docetaxel) n=54 participants at risk Participants receive trametinib PO on days 1-21. Participants also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Trametinib: Given PO
Metabolism and nutrition disorders Hypokalemia	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Blood and lymphatic system disorders Febrile neutropenia	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Cardiac disorders Myocardial infarction	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Cardiac disorders Pericardial effusion	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Cardiac disorders Sinus tachycardia	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Abdominal pain	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Diarrhea	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Gastric hemorrhage	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
General disorders Fever	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Infections and infestations Lung infection	13.0% 7/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Infections and infestations Sepsis	9.3% 5/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Infections and infestations Urinary tract infection	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Infections and infestations Wound infection	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Investigations Aspartate aminotransferase increased	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Investigations Ejection fraction decreased	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Investigations Weight loss	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Metabolism and nutrition disorders Anorexia	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Metabolism and nutrition disorders Dehydration	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Metabolism and nutrition disorders Hyperglycemia	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Gastrointestinal disorders-Other	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Mucositis oral	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Nausea	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Vomiting	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
General disorders Fatigue	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Blood and lymphatic system disorders Anemia	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Musculoskeletal and connective tissue disorders Flank pain	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Nervous system disorders Stroke	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Psychiatric disorders Confusion	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Vascular disorders Hypertension	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Vascular disorders Hypotension	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Vascular disorders Thromboembolic event	5.6% 3/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.

Other adverse events

Measure	Treatment (Trametinib, Docetaxel) n=54 participants at risk Participants receive trametinib PO on days 1-21. Participants also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Trametinib: Given PO
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Resp, thoracic and mediastinal disorders - Other	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Sore throat	7.4% 4/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Voice alteration	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Wheezing	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Skin and subcutaneous tissue disorders Alopecia	20.4% 11/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Skin and subcutaneous tissue disorders Dry skin	31.5% 17/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Skin and subcutaneous tissue disorders Erythema multiforme	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Skin and subcutaneous tissue disorders Nail discoloration	7.4% 4/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Skin and subcutaneous tissue disorders Nail loss	7.4% 4/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Skin and subcutaneous tissue disorders Periorbital edema	11.1% 6/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Skin and subcutaneous tissue disorders Pruritus	14.8% 8/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Skin and subcutaneous tissue disorders Rash acneiform	31.5% 17/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Skin and subcutaneous tissue disorders Rash maculo-papular	37.0% 20/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Skin and subcutaneous tissue disorders Scalp pain	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	16.7% 9/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Skin and subcutaneous tissue disorders Skin ulceration	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Vascular disorders Flushing	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Vascular disorders Hot flashes	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Cardiac disorders Pericardial effusion	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Cardiac disorders Restrictive cardiomyopathy	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Cardiac disorders Sinus bradycardia	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Cardiac disorders Sinus tachycardia	13.0% 7/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Cardiac disorders Ventricular arrhythmia	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Ear and labyrinth disorders Ear pain	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Ear and labyrinth disorders External ear inflammation	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Ear and labyrinth disorders Tinnitus	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Ear and labyrinth disorders Vertigo	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Endocrine disorders Adrenal insufficiency	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Eye disorders Blurred vision	9.3% 5/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Eye disorders Conjunctivitis	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Eye disorders Dry eye	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Eye disorders Eye disorders-Other	7.4% 4/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Eye disorders Glaucoma	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Eye disorders Watering eyes	9.3% 5/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Abdominal pain	24.1% 13/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Anal pain	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Bloating	5.6% 3/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Colitis	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Colonic obstruction	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Constipation	40.7% 22/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Dental caries	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Diarrhea	72.2% 39/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Dry mouth	13.0% 7/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Dyspepsia	5.6% 3/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Dysphagia	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Flatulence	5.6% 3/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Vascular disorders Hypertension	27.8% 15/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Gastroesophageal reflux disease	5.6% 3/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Gastrointestinal disorders-Other	11.1% 6/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Mucositis oral	33.3% 18/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Nausea	59.3% 32/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Oral hemorrhage	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Oral pain	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Stomach pain	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Gastrointestinal disorders Vomiting	29.6% 16/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
General disorders Chills	7.4% 4/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
General disorders Edema face	5.6% 3/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
General disorders Edema limbs	35.2% 19/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
General disorders Fatigue	81.5% 44/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
General disorders Fever	22.2% 12/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
General disorders Flu like symptoms	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
General disorders General disorders and admin site conditions - Other	7.4% 4/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
General disorders Infusion related reaction	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
General disorders Malaise	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
General disorders Multi-organ failure	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
General disorders Neck edema	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
General disorders Non-cardiac chest pain	5.6% 3/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
General disorders Pain	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Infections and infestations Bronchial infection	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Infections and infestations Infections and infestations-Other	7.4% 4/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Infections and infestations Laryngitis	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Infections and infestations Lung infection	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Infections and infestations Mucosal infection	7.4% 4/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Infections and infestations Papulopustular rash	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Infections and infestations Paronychia	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Infections and infestations Periorbital infection	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Infections and infestations Pharyngitis	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Infections and infestations Rash pustular	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Infections and infestations Sepsis	5.6% 3/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Infections and infestations Sinusitis	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Infections and infestations Skin infection	7.4% 4/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Infections and infestations Upper respiratory infection	13.0% 7/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Infections and infestations Urinary tract infection	5.6% 3/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Infections and infestations Vaginal infection	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Injury, poisoning and procedural complications Bruising	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Injury, poisoning and procedural complications Fall	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Investigations Alanine aminotransferase increased	11.1% 6/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Investigations Alkaline phosphatase increased	27.8% 15/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Investigations Aspartate aminotransferase increased	24.1% 13/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Investigations Blood bilirubin increased	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Investigations Cholesterol high	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Investigations Creatinine increased	11.1% 6/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Investigations Electrocardiogram QT corrected interval prolonged	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Investigations INR increased	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Investigations Investigations-Other	7.4% 4/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Investigations Lymphocyte count decreased	18.5% 10/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Investigations Neutrophil count decreased	20.4% 11/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Investigations Platelet count decreased	16.7% 9/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Investigations Weight gain	5.6% 3/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Investigations Weight loss	11.1% 6/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Investigations White blood cell decreased	18.5% 10/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Metabolism and nutrition disorders Acidosis	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Metabolism and nutrition disorders Anorexia	29.6% 16/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Metabolism and nutrition disorders Dehydration	20.4% 11/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Metabolism and nutrition disorders Hypercalcemia	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Metabolism and nutrition disorders Hyperglycemia	13.0% 7/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Metabolism and nutrition disorders Hyperkalemia	7.4% 4/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Metabolism and nutrition disorders Hypermagnesemia	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Metabolism and nutrition disorders Hypernatremia	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Metabolism and nutrition disorders Hypoalbuminemia	44.4% 24/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Metabolism and nutrition disorders Hypocalcemia	24.1% 13/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Metabolism and nutrition disorders Hypoglycemia	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Metabolism and nutrition disorders Hypokalemia	14.8% 8/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Metabolism and nutrition disorders Hypomagnesemia	14.8% 8/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Metabolism and nutrition disorders Hyponatremia	33.3% 18/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Metabolism and nutrition disorders Hypophosphatemia	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Musculoskeletal and connective tissue disorders Arthralgia	9.3% 5/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Musculoskeletal and connective tissue disorders Arthritis	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Musculoskeletal and connective tissue disorders Back pain	13.0% 7/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Vascular disorders Hypotension	14.8% 8/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Musculoskeletal and connective tissue disorders Bone pain	5.6% 3/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Musculoskeletal and connective tissue disorders Chest wall pain	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Musculoskeletal and connective tissue disorders Flank pain	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	13.0% 7/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tiss disorder - Other	9.3% 5/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Musculoskeletal and connective tissue disorders Myalgia	11.1% 6/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	5.6% 3/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Nervous system disorders Ataxia	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Nervous system disorders Depressed level of consciousness	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Nervous system disorders Dizziness	11.1% 6/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Nervous system disorders Dysgeusia	14.8% 8/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Nervous system disorders Dysphasia	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Nervous system disorders Encephalopathy	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Nervous system disorders Headache	9.3% 5/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Nervous system disorders Lethargy	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Vascular disorders Thromboembolic event	5.6% 3/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Nervous system disorders Nervous system disorders-Other	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Nervous system disorders Peripheral sensory neuropathy	13.0% 7/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Nervous system disorders Tremor	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Psychiatric disorders Anxiety	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Psychiatric disorders Confusion	9.3% 5/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Psychiatric disorders Depression	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Psychiatric disorders Hallucinations	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Psychiatric disorders Insomnia	9.3% 5/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Renal and urinary disorders Acute kidney injury	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Renal and urinary disorders Proteinuria	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Renal and urinary disorders Renal and urinary disorders-Other	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Vascular disorders Vascular disorders-Other	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Cough	24.1% 13/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 18/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Epistaxis	20.4% 11/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Hiccups	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Hoarseness	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Nasal congestion	13.0% 7/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.7% 2/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	9.3% 5/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Postnasal drip	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Productive cough	9.3% 5/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Blood and lymphatic system disorders Anemia	50.0% 27/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Cardiac disorders Atrial fibrillation	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Cardiac disorders Cardiac disorders-Other	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.
Cardiac disorders Left ventricular systolic dysfunction	1.9% 1/54 • Duration of treatment and follow up until death or 3 years post registration 54 participants who were eligible and received protocol therapy were assessed for AEs.

Additional Information

Lung Committee Statistician

SWOG Statistics and Data Management Center

Phone: 2066674623

Email: jmiao@fredhutch.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60