Trial Outcomes & Findings for Rucaparib in Treating Patients With Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial) (NCT NCT03845296)

Last Updated: 2025-05-21

Results Overview

Percentage of participants with a complete or partial, confirmed or unconfirmed response. Complete Response (CR): Complete disappearance of all target and non-target lesions. No new lesions. No disease related symptoms. Any lymph nodes (whether target or non-target) must have reduction in short axis to \< 1.0 cm. All disease must be assessed using the same technique as baseline. Partial Response (PR): Applies only to participants with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

64 participants

Primary outcome timeframe

From date of registration to a maximum of 3 years or death

Results posted on

2025-05-21

Participant Flow

64 participants were initially enrolled. Three participants were ineligible, one was not analyzable and one withdrew consent prior to starting the study drug. In all, 59 participants were eligible and included in the analysis: 25 in the squamous cohort and 34 in the non-squamous cohort.

Participant milestones

Participant milestones
Measure	Cohort 1: Squamous Participants with squamous cell lung cancer	Cohort 2: Non-Squamous Participants with non-squamous cell lung cancer (adenocarcinoma, large cell, NSCLC NOS, mixed histology with any non-squamous component)
Overall Study STARTED	25	34
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	25	34

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Squamous Participants with squamous cell lung cancer	Cohort 2: Non-Squamous Participants with non-squamous cell lung cancer (adenocarcinoma, large cell, NSCLC NOS, mixed histology with any non-squamous component)
Overall Study On Treatment	2	1
Overall Study Adverse Event	4	11
Overall Study Refusal unrelated to adverse event	0	1
Overall Study Progression/relapse	14	18
Overall Study Death	4	0
Overall Study Other - not protocol specified	1	3

Baseline Characteristics

Rucaparib in Treating Patients With Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Squamous n=25 Participants Participants with squamous cell lung cancer	Cohort 2: Non-Squamous n=34 Participants Participants with non-squamous cell lung cancer (adenocarcinoma, large cell, NSCLC NOS, mixed histology with any non-squamous component)	Total n=59 Participants Total of all reporting groups
Age, Continuous	63.9 years n=5 Participants	69.1 years n=7 Participants	65.7 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	33 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	30 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Prior Lines of Treatment for Stage IV Disease 0	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Prior Lines of Treatment for Stage IV Disease 1	9 Participants n=5 Participants	16 Participants n=7 Participants	25 Participants n=5 Participants
Prior Lines of Treatment for Stage IV Disease 2 or more	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Performance Status 0	4 Participants n=5 Participants	11 Participants n=7 Participants	15 Participants n=5 Participants
Performance Status 1	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Weight Loss in the Past 6 Months < 5%	16 Participants n=5 Participants	24 Participants n=7 Participants	40 Participants n=5 Participants
Weight Loss in the Past 6 Months 5 - < 10%	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Weight Loss in the Past 6 Months 10 - < 20%	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Weight Loss in the Past 6 Months >= 20%	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Weight Loss in the Past 6 Months Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Smoking Status Current Smoker	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Smoking Status Former Smoker	15 Participants n=5 Participants	20 Participants n=7 Participants	35 Participants n=5 Participants
Smoking Status Never Smoker	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Study Biomarker Status LOH Only	16 Participants n=5 Participants	20 Participants n=7 Participants	36 Participants n=5 Participants
Study Biomarker Status LOH and BRCA1	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Study Biomarker Status LOH and BRCA2	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Study Biomarker Status BRCA1 Only	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Study Biomarker Status BRCA2 Only	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of registration to a maximum of 3 years or death

Population: Eligible and evaluable participants

Outcome measures

Outcome measures
Measure	Cohort 1: Squamous n=25 Participants Participants with squamous cell lung cancer	Cohort 2: Non-Squamous n=34 Participants Participants with non-squamous cell lung cancer (adenocarcinoma, large cell, NSCLC NOS, mixed histology with any non-squamous component)
Overall Response Rate	8 Percentage of participants Interval 0.0 to 19.0	12 Percentage of participants Interval 1.0 to 23.0

SECONDARY outcome

Timeframe: From date of registration to a maximum of 3 years or death

Population: Eligible and evaluable participants

Time from date of registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause. Participants last known to be alive without report of progression are censored at date of last disease assessment. For participants with a missing scan (or consecutive missing scans) whose subsequent scan determines progression, the expected date of the first missing scan (as defined by the disease assessment schedule) is used as the date of progression. Progression: One or more of: 20% increase in sum of diameters of target lesions over smallest sum observed and absolute increase of at least 0.5cm; Unequivocal progression of non-measurable disease in opinion of the treating physician; Appearance of any new lesion/site; Death due to disease w/o prior progression or symptomatic deterioration Symptomatic deterioration: Global deterioration of health status requiring treatment discontinuation w/o objective evidence of progression

Outcome measures

Outcome measures
Measure	Cohort 1: Squamous n=25 Participants Participants with squamous cell lung cancer	Cohort 2: Non-Squamous n=34 Participants Participants with non-squamous cell lung cancer (adenocarcinoma, large cell, NSCLC NOS, mixed histology with any non-squamous component)
Investigator-Assessed Progression-Free Survival (IA-PFS)	2.9 months Interval 1.6 to 6.2	3.5 months Interval 1.6 to 4.6

SECONDARY outcome

Timeframe: From date of registration to a maximum of 3 years or death

Population: Eligible and evaluable participants

Time from date of registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact.

Outcome measures

Outcome measures
Measure	Cohort 1: Squamous n=25 Participants Participants with squamous cell lung cancer	Cohort 2: Non-Squamous n=34 Participants Participants with non-squamous cell lung cancer (adenocarcinoma, large cell, NSCLC NOS, mixed histology with any non-squamous component)
Overall Survival (OS)	8.2 months Interval 4.4 to 15.3	7.8 months Interval 5.0 to 11.4

SECONDARY outcome

Timeframe: From date of registration to a maximum of 3 years or death

Population: Eligible and evaluable participants who had a response

Time from date of first documentation of response (complete or partial) to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause among participants who achieve a response. Participants last known to be alive without report of progression are censored at date of last disease assessment. For participants with a missing scan (or consecutive missing scans) whose subsequent scan determines progression, the expected date of the first missing scan will be used as the date of progression.

Outcome measures

Outcome measures
Measure	Cohort 1: Squamous n=2 Participants Participants with squamous cell lung cancer	Cohort 2: Non-Squamous n=4 Participants Participants with non-squamous cell lung cancer (adenocarcinoma, large cell, NSCLC NOS, mixed histology with any non-squamous component)
Duration of Response (DoR)	NA months Median not reached	14.9 months Interval 9.9 to Insufficient follow-up data

SECONDARY outcome

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

Population: Eligible participants who received at least one dose of protocol treatment

Only adverse events that are possibly, probably or definitely related to study drug are reported. CTCAE Version 5.0 was used for routine toxicity reporting and serious adverse events (SAEs).

Outcome measures

Outcome measures
Measure	Cohort 1: Squamous n=59 Participants Participants with squamous cell lung cancer	Cohort 2: Non-Squamous Participants with non-squamous cell lung cancer (adenocarcinoma, large cell, NSCLC NOS, mixed histology with any non-squamous component)
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Alanine aminotransferase increased	2 Participants	—
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Alkaline phosphatase increased	1 Participants	—
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Anemia	13 Participants	—
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Aspartate aminotransferase increased	1 Participants	—
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Blood bilirubin increased	1 Participants	—
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Chronic kidney disease	1 Participants	—
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Confusion	1 Participants	—
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dyspnea	2 Participants	—
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Fatigue	5 Participants	—
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Generalized muscle weakness	2 Participants	—
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypertension	1 Participants	—
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypokalemia	2 Participants	—
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Lymphocyte count decreased	5 Participants	—
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Nausea	1 Participants	—
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Neutrophil count decreased	2 Participants	—
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Personality change	1 Participants	—
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Platelet count decreased	3 Participants	—
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Rash maculo-papular	1 Participants	—
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Vomiting	1 Participants	—
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs White blood cell decreased	3 Participants	—

Adverse Events

Rucaparib

Serious events: 32 serious events

Other events: 57 other events

Deaths: 50 deaths

Serious adverse events

Serious adverse events
Measure	Rucaparib n=59 participants at risk Participants receive rucaparib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	18.6% 11/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Cardiac disorders Atrial fibrillation	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Cardiac disorders Cardiac arrest	3.4% 2/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Cardiac disorders Chest pain - cardiac	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Cardiac disorders Myocardial infarction	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Gastrointestinal disorders Abdominal pain	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Gastrointestinal disorders Diarrhea	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Gastrointestinal disorders Gastric hemorrhage	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Gastrointestinal disorders Gastrointestinal disorders-Other	3.4% 2/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Gastrointestinal disorders Nausea	3.4% 2/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Gastrointestinal disorders Small intestinal perforation	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Gastrointestinal disorders Vomiting	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
General disorders Death NOS	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
General disorders Disease progression	6.8% 4/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
General disorders Fatigue	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
General disorders Fever	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
General disorders Pain	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Infections and infestations Lung infection	8.5% 5/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Injury, poisoning and procedural complications Fall	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Investigations Alanine aminotransferase increased	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Investigations Aspartate aminotransferase increased	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Investigations Blood bilirubin increased	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Investigations Cardiac troponin I increased	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Investigations Neutrophil count decreased	3.4% 2/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Investigations Platelet count decreased	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Investigations White blood cell decreased	3.4% 2/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Metabolism and nutrition disorders Acidosis	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Metabolism and nutrition disorders Anorexia	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Metabolism and nutrition disorders Dehydration	3.4% 2/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Metabolism and nutrition disorders Hyperkalemia	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Metabolism and nutrition disorders Hypoalbuminemia	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Metabolism and nutrition disorders Hypokalemia	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Metabolism and nutrition disorders Hypomagnesemia	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Metabolism and nutrition disorders Hypophosphatemia	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Metabolism and nutrition disorders Metabolism and nutrition disorders-Other	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.1% 3/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Psychiatric disorders Agitation	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Psychiatric disorders Confusion	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Psychiatric disorders Delirium	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Psychiatric disorders Personality change	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Renal and urinary disorders Chronic kidney disease	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Respiratory, thoracic and mediastinal disorders Aspiration	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	3.4% 2/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Respiratory, thoracic and mediastinal disorders Cough	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.9% 7/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.1% 3/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Respiratory, thoracic and mediastinal disorders Respiratory failure	6.8% 4/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders-Ot	3.4% 2/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Respiratory, thoracic and mediastinal disorders Wheezing	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.7% 1/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Vascular disorders Hypertension	3.4% 2/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Vascular disorders Thromboembolic event	3.4% 2/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.

Other adverse events

Other adverse events
Measure	Rucaparib n=59 participants at risk Participants receive rucaparib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	66.1% 39/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Cardiac disorders Sinus tachycardia	5.1% 3/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Eye disorders Blurred vision	8.5% 5/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Gastrointestinal disorders Constipation	25.4% 15/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Gastrointestinal disorders Diarrhea	28.8% 17/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Gastrointestinal disorders Dyspepsia	13.6% 8/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Gastrointestinal disorders Mucositis oral	8.5% 5/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Gastrointestinal disorders Nausea	49.2% 29/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Gastrointestinal disorders Vomiting	23.7% 14/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
General disorders Chills	6.8% 4/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
General disorders Edema limbs	13.6% 8/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
General disorders Fatigue	61.0% 36/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
General disorders Fever	6.8% 4/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
General disorders Pain	8.5% 5/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Infections and infestations Lung infection	10.2% 6/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Injury, poisoning and procedural complications Fall	5.1% 3/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Investigations Alanine aminotransferase increased	35.6% 21/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Investigations Alkaline phosphatase increased	33.9% 20/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Investigations Aspartate aminotransferase increased	40.7% 24/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Investigations Blood bilirubin increased	16.9% 10/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Investigations Blood lactate dehydrogenase increased	6.8% 4/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Investigations Cholesterol high	25.4% 15/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Investigations Creatinine increased	33.9% 20/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Investigations Investigations-Other	8.5% 5/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Investigations Lymphocyte count decreased	37.3% 22/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Investigations Neutrophil count decreased	13.6% 8/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Investigations Platelet count decreased	37.3% 22/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Investigations Weight loss	22.0% 13/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Investigations White blood cell decreased	23.7% 14/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Metabolism and nutrition disorders Anorexia	23.7% 14/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Metabolism and nutrition disorders Dehydration	6.8% 4/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Metabolism and nutrition disorders Hypercalcemia	8.5% 5/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Metabolism and nutrition disorders Hyperglycemia	20.3% 12/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Metabolism and nutrition disorders Hypoalbuminemia	28.8% 17/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Metabolism and nutrition disorders Hypocalcemia	11.9% 7/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Metabolism and nutrition disorders Hypokalemia	16.9% 10/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Metabolism and nutrition disorders Hypomagnesemia	8.5% 5/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Metabolism and nutrition disorders Hyponatremia	37.3% 22/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Metabolism and nutrition disorders Hypophosphatemia	5.1% 3/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Metabolism and nutrition disorders Metabolism and nutrition disorders-Other	5.1% 3/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Musculoskeletal and connective tissue disorders Arthralgia	6.8% 4/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Musculoskeletal and connective tissue disorders Back pain	10.2% 6/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	16.9% 10/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Musculoskeletal and connective tissue disorders Myalgia	10.2% 6/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Musculoskeletal and connective tissue disorders Pain in extremity	6.8% 4/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Nervous system disorders Dizziness	16.9% 10/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Nervous system disorders Dysgeusia	27.1% 16/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Nervous system disorders Headache	6.8% 4/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Nervous system disorders Peripheral sensory neuropathy	8.5% 5/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Psychiatric disorders Anxiety	5.1% 3/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Psychiatric disorders Confusion	5.1% 3/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Renal and urinary disorders Chronic kidney disease	8.5% 5/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Respiratory, thoracic and mediastinal disorders Cough	20.3% 12/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Respiratory, thoracic and mediastinal disorders Dyspnea	32.2% 19/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Respiratory, thoracic and mediastinal disorders Hoarseness	5.1% 3/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Skin and subcutaneous tissue disorders Photosensitivity	5.1% 3/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Skin and subcutaneous tissue disorders Pruritus	5.1% 3/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.1% 3/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Vascular disorders Hot flashes	5.1% 3/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Vascular disorders Hypertension	23.7% 14/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Vascular disorders Hypotension	11.9% 7/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.
Vascular disorders Thromboembolic event	5.1% 3/59 • Duration of treatment and follow-up until death or 3 years post registration CTCAE Version 5.0 was used for routine toxicity reporting and Serious Adverse Event (SAE) reporting. 59 participants were assessed for adverse events: 25 in the squamous cohort and 34 in the non-squamous cohort.

Additional Information

Lung Committee Statistician

SWOG Statistics and Data Management Center

Phone: 2066674623

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60