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

• 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: SWOG Cancer Research Network
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Pre-Screened Group	Screened at Progression Group	Total
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
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%

Outcome Measures

1. Primary Outcome

Title	Screen Success Rate
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.

Outcome Measure Data

Analysis Population Description

Screened participants who were assigned to a therapeutic sub-study.

Arm/Group Title	Assigned Participants
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%

Adverse Events

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
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
Serious Adverse Events
	Recurrent Stage IV Squamous Cell Lung Cancer
	Affected / at Risk (%)
Total	0/0
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Lung Committee Statistician
• Organization: SWOG Statistics & Data Management Center
• Phone: 2066674623
• EMail: kmini@fredhutch.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Redman MW, Papadimitrakopoulou VA, Minichiello K, Hirsch FR, Mack PC, Schwartz LH, Vokes E, Ramalingam S, Leighl N, Bradley J, Miao J, Moon J, Highleyman L, Miwa C, LeBlanc ML, Malik S, Miller VA, Sigal EV, Adam S, Wholley D, Sigman C, Smolich B, Blanke CD, Kelly K, Gandara DR, Herbst RS. Biomarker-driven therapies for previously treated squamous non-small-cell lung cancer (Lung-MAP SWOG S1400): a biomarker-driven master protocol. Lancet Oncol. 2020 Dec;21(12):1589-1601. doi: 10.1016/S1470-2045(20)30475-7. Epub 2020 Oct 27.

Middleton G, Crack LR, Popat S, Swanton C, Hollingsworth SJ, Buller R, Walker I, Carr TH, Wherton D, Billingham LJ. The National Lung Matrix Trial: translating the biology of stratification in advanced non-small-cell lung cancer. Ann Oncol. 2015 Dec;26(12):2464-9. doi: 10.1093/annonc/mdv394. Epub 2015 Sep 25.

• 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