This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02154490
Recruitment Status : Completed
First Posted : June 3, 2014
Results First Posted : January 31, 2023
Last Update Posted : June 1, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
SWOG Cancer Research Network

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Conditions Recurrent Squamous Cell Lung Carcinoma
Stage IV Squamous Cell Lung Carcinoma AJCC v7
Interventions Drug: Docetaxel
Biological: Durvalumab
Drug: Erlotinib Hydrochloride
Drug: FGFR Inhibitor AZD4547
Biological: Ipilimumab
Other: Laboratory Biomarker Analysis
Biological: Nivolumab
Drug: Palbociclib
Other: Pharmacological Study
Biological: Rilotumumab
Drug: Talazoparib
Drug: Taselisib
Biological: Tremelimumab
Enrollment 1864
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Recurrent Stage IV Squamous Cell Lung Cancer
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 1864
Completed 655
Not Completed 1209
Reason Not Completed
No tissue submitted             23
No biomarker results             167
Not assigned to a sub-study             270
Did not register to a sub-study             749
Arm/Group Title Pre-Screened Group Screened at Progression Group Total
Hide Arm/Group Description 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. Participants who were screened at disease progression. Total of all reporting groups
Overall Number of Baseline Participants 711 1079 1790
Hide Baseline Analysis Population Description
Eligible participants enrolled to be screened on Lung-MAP
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 711 participants 1079 participants 1790 participants
67
(39 to 90)
67
(23 to 92)
67
(23 to 92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 711 participants 1079 participants 1790 participants
Female
245
  34.5%
337
  31.2%
582
  32.5%
Male
466
  65.5%
742
  68.8%
1208
  67.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 711 participants 1079 participants 1790 participants
Hispanic or Latino
16
   2.3%
30
   2.8%
46
   2.6%
Not Hispanic or Latino
679
  95.5%
1032
  95.6%
1711
  95.6%
Unknown or Not Reported
16
   2.3%
17
   1.6%
33
   1.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 711 participants 1079 participants 1790 participants
American Indian or Alaska Native
5
   0.7%
9
   0.8%
14
   0.8%
Asian
15
   2.1%
27
   2.5%
42
   2.3%
Native Hawaiian or Other Pacific Islander
4
   0.6%
3
   0.3%
7
   0.4%
Black or African American
74
  10.4%
95
   8.8%
169
   9.4%
White
598
  84.1%
919
  85.2%
1517
  84.7%
More than one race
0
   0.0%
3
   0.3%
3
   0.2%
Unknown or Not Reported
15
   2.1%
23
   2.1%
38
   2.1%
Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 711 participants 1079 participants 1790 participants
0
199
  28.0%
275
  25.5%
474
  26.5%
1
499
  70.2%
743
  68.9%
1242
  69.4%
2
13
   1.8%
61
   5.7%
74
   4.1%
[1]
Measure Description:

Participants were graded according to the Zubrod Performance Status Scale.

0- Fully active, able to carry on all pre-disease performance without restriction. 1- Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work. 2- Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours.

Prior to Dec 18, 2015, a performance status of 0-2 was allowed; after then, only a performance status of 0-1 was allowed.

Tobacco Smoking History  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 711 participants 1079 participants 1790 participants
Current
243
  34.2%
375
  34.8%
618
  34.5%
Former
437
  61.5%
665
  61.6%
1102
  61.6%
Never
31
   4.4%
39
   3.6%
70
   3.9%
Previous Lines of Treatment for Stage IV or Recurrent Disease   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 711 participants 1079 participants 1790 participants
0 or 1
521
  73.3%
886
  82.1%
1407
  78.6%
2
132
  18.6%
122
  11.3%
254
  14.2%
3 or more
58
   8.2%
71
   6.6%
129
   7.2%
[1]
Measure Description: Prior to May 26, 2015, the study was a second line-only trial, allowing only participants with one line of previous therapy for stage IV or recurrent disease to be screened.
Weight Loss in the Past 6 Months  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 711 participants 1079 participants 1790 participants
< 5% or weight gain
513
  72.2%
759
  70.3%
1272
  71.1%
5-9%
103
  14.5%
195
  18.1%
298
  16.6%
10-19%
81
  11.4%
110
  10.2%
191
  10.7%
>= 20%
12
   1.7%
10
   0.9%
22
   1.2%
Unknown
2
   0.3%
5
   0.5%
7
   0.4%
NCTN Group   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 711 participants 1079 participants 1790 participants
SWOG
322
  45.3%
567
  52.5%
889
  49.7%
Alliance
167
  23.5%
209
  19.4%
376
  21.0%
ECOG-ACRIN
144
  20.3%
170
  15.8%
314
  17.5%
NRG Oncology
72
  10.1%
121
  11.2%
193
  10.8%
CCTG
6
   0.8%
12
   1.1%
18
   1.0%
[1]
Measure Description: The CCTG participated between December 18, 2015 and July 12, 2018, and closed the study due to challenges with drug distribution across the US-Canadian border.
Type of Site  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 711 participants 1079 participants 1790 participants
Community (NCORP)
262
  36.8%
424
  39.3%
686
  38.3%
Member
237
  33.3%
367
  34.0%
604
  33.7%
Lead academic
212
  29.8%
288
  26.7%
500
  27.9%
1.Primary Outcome
Title Screen Success Rate
Hide Description

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.

Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Screened participants who were assigned to a therapeutic sub-study.
Arm/Group Title Assigned Participants
Hide Arm/Group Description:
Screened participants who were assigned to a therapeutic sub-study.
Overall Number of Participants Analyzed 1404
Measure Type: Count of Participants
Unit of Measure: Participants
655
  46.7%
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse event data were not collected as this was a screening trial. For participants who enrolled in a sub-study, AE data are reported separately within each sub-study.
 
Arm/Group Title Recurrent Stage IV Squamous Cell Lung Cancer
Hide Arm/Group Description 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.
All-Cause Mortality
Recurrent Stage IV Squamous Cell Lung Cancer
Affected / at Risk (%)
Total   0/0 
Hide Serious Adverse Events
Recurrent Stage IV Squamous Cell Lung Cancer
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Recurrent Stage IV Squamous Cell Lung Cancer
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lung Committee Statistician
Organization: SWOG Statistics & Data Management Center
Phone: 2066674623
EMail: kmini@fredhutch.org
Layout table for additonal information
Responsible Party: SWOG Cancer Research Network
ClinicalTrials.gov Identifier: NCT02154490    
Other Study ID Numbers: S1400
NCI-2014-00627 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
S1400A
S1400E
S1400I
S1400C
S1400
S1400D
S1400B
S1400 ( Other Identifier: SWOG )
S1400 ( Other Identifier: CTEP )
U10CA180888 ( U.S. NIH Grant/Contract )
First Submitted: May 30, 2014
First Posted: June 3, 2014
Results First Submitted: November 30, 2022
Results First Posted: January 31, 2023
Last Update Posted: June 1, 2023