Trial Outcomes & Findings for Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer (NCT NCT02154490)
NCT ID: NCT02154490
Last Updated: 2023-06-01
Results Overview
Percentage of participants that registered to a therapeutic sub-study out of those who received a sub-study assignment. To receive a sub-study assignment, enrolled participants must have submitted tissue, had biomarker results, and been matched to a therapeutic sub-study.
Recruitment status
COMPLETED
Target enrollment
1864 participants
Primary outcome timeframe
From date of registration to pre-screening or screening component until sub-study registration or death, a median of 3.5 months (IQR 2.0-6.0) in the pre-screened group and 0.9 months (IQR 0.7-1.1) in the screened at progression group.
Results posted on
2023-06-01
Participant Flow
Between July 8, 2014, and Jan 28, 2019, 1864 participants enrolled and 1841 (98.9%) submitted tissue. 1674 (90.9%) of 1841 participants had biomarker results, and 1404 (83.9%) of 1674 participants received a substudy assignment. Of the assigned participants, 655 (46.7%) registered to a substudy.
Participant milestones
| Measure |
Recurrent Stage IV Squamous Cell Lung Cancer
Participants with stage IV or recurrent squamous non-small-cell lung cancer who were previously treated with platinum-based chemotherapy enrolled to the master protocol. Participants were screened using the FoundationOne assay for next-generation sequencing.
|
|---|---|
|
Overall Study
STARTED
|
1864
|
|
Overall Study
COMPLETED
|
655
|
|
Overall Study
NOT COMPLETED
|
1209
|
Reasons for withdrawal
| Measure |
Recurrent Stage IV Squamous Cell Lung Cancer
Participants with stage IV or recurrent squamous non-small-cell lung cancer who were previously treated with platinum-based chemotherapy enrolled to the master protocol. Participants were screened using the FoundationOne assay for next-generation sequencing.
|
|---|---|
|
Overall Study
No tissue submitted
|
23
|
|
Overall Study
No biomarker results
|
167
|
|
Overall Study
Not assigned to a sub-study
|
270
|
|
Overall Study
Did not register to a sub-study
|
749
|
Baseline Characteristics
Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Pre-Screened Group
n=711 Participants
Participants who were screened for biomarkers during previous treatment for stage IV or recurrent disease prior to progression. The pre-screening option was added to the study on May 26, 2015, 11 months after activation.
|
Screened at Progression Group
n=1079 Participants
Participants who were screened at disease progression.
|
Total
n=1790 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
67 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
245 Participants
n=5 Participants
|
337 Participants
n=7 Participants
|
582 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
466 Participants
n=5 Participants
|
742 Participants
n=7 Participants
|
1208 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
679 Participants
n=5 Participants
|
1032 Participants
n=7 Participants
|
1711 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
74 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
598 Participants
n=5 Participants
|
919 Participants
n=7 Participants
|
1517 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Performance Status
0
|
199 Participants
n=5 Participants
|
275 Participants
n=7 Participants
|
474 Participants
n=5 Participants
|
|
Performance Status
1
|
499 Participants
n=5 Participants
|
743 Participants
n=7 Participants
|
1242 Participants
n=5 Participants
|
|
Performance Status
2
|
13 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Tobacco Smoking History
Current
|
243 Participants
n=5 Participants
|
375 Participants
n=7 Participants
|
618 Participants
n=5 Participants
|
|
Tobacco Smoking History
Former
|
437 Participants
n=5 Participants
|
665 Participants
n=7 Participants
|
1102 Participants
n=5 Participants
|
|
Tobacco Smoking History
Never
|
31 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Previous Lines of Treatment for Stage IV or Recurrent Disease
0 or 1
|
521 Participants
n=5 Participants
|
886 Participants
n=7 Participants
|
1407 Participants
n=5 Participants
|
|
Previous Lines of Treatment for Stage IV or Recurrent Disease
2
|
132 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
|
Previous Lines of Treatment for Stage IV or Recurrent Disease
3 or more
|
58 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Weight Loss in the Past 6 Months
< 5% or weight gain
|
513 Participants
n=5 Participants
|
759 Participants
n=7 Participants
|
1272 Participants
n=5 Participants
|
|
Weight Loss in the Past 6 Months
5-9%
|
103 Participants
n=5 Participants
|
195 Participants
n=7 Participants
|
298 Participants
n=5 Participants
|
|
Weight Loss in the Past 6 Months
10-19%
|
81 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Weight Loss in the Past 6 Months
>= 20%
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Weight Loss in the Past 6 Months
Unknown
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
NCTN Group
SWOG
|
322 Participants
n=5 Participants
|
567 Participants
n=7 Participants
|
889 Participants
n=5 Participants
|
|
NCTN Group
Alliance
|
167 Participants
n=5 Participants
|
209 Participants
n=7 Participants
|
376 Participants
n=5 Participants
|
|
NCTN Group
ECOG-ACRIN
|
144 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
314 Participants
n=5 Participants
|
|
NCTN Group
NRG Oncology
|
72 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
NCTN Group
CCTG
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Type of Site
Community (NCORP)
|
262 Participants
n=5 Participants
|
424 Participants
n=7 Participants
|
686 Participants
n=5 Participants
|
|
Type of Site
Member
|
237 Participants
n=5 Participants
|
367 Participants
n=7 Participants
|
604 Participants
n=5 Participants
|
|
Type of Site
Lead academic
|
212 Participants
n=5 Participants
|
288 Participants
n=7 Participants
|
500 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of registration to pre-screening or screening component until sub-study registration or death, a median of 3.5 months (IQR 2.0-6.0) in the pre-screened group and 0.9 months (IQR 0.7-1.1) in the screened at progression group.Population: Screened participants who were assigned to a therapeutic sub-study.
Percentage of participants that registered to a therapeutic sub-study out of those who received a sub-study assignment. To receive a sub-study assignment, enrolled participants must have submitted tissue, had biomarker results, and been matched to a therapeutic sub-study.
Outcome measures
| Measure |
Assigned Participants
n=1404 Participants
Screened participants who were assigned to a therapeutic sub-study.
|
|---|---|
|
Screen Success Rate
|
655 Participants
|
Adverse Events
Recurrent Stage IV Squamous Cell Lung Cancer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lung Committee Statistician
SWOG Statistics & 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