Lung Cancer Clinical Trial

A Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer

Summary

This trial will evaluate the efficacy and safety of various therapies in patients with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated non-small cell lung cancer (NSCLC) tumors that meet protocol-specified biomarker criteria

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria for Neoadjuvant Therapy:

Pathologically documented NSCLC: Stage IB, IIA, IIB, IIIA, or selected IIIB, including T3N2, or T4 (by size criteria, not by mediastinal invasion) NSCLC (based on the 8th edition of the American Joint Committee on Cancer [AJCC] Non-Small Cell Lung Cancer Staging system
T4 primary NSCLC will be allowed only on the basis of size
All patients will undergo clinical staging using CT and PET scanning, as well as brain imaging using MRI. Invasive mediastinal staging by either mediastinoscopy or endo- bronchial ultrasonography is highly encouraged for patients with radiographically suspected mediastinal nodal disease (ie, N2) but not mandated if the CT or PET scans showed no evidence of N2 disease.
Molecular testing results from CLIA-certified laboratories and showing at least one of the following abnormalities: ALK fusion, ROS1 fusion, NTRK1/2/3 fusion; BRAF V600 mutation; RET fusion, PD-L1 expression in ≥ 1% tumor cells as determined by FDA-approved test
Measurable disease, as defined by RECIST v1.1
Evaluated by the attending surgeon prior to study enrollment to verify that the primary tumor and any involved lymph nodes are technically completely resectable and verify that the participant is medically operable
Adequate pulmonary function to be eligible for surgical resection with curative intent
Adequate cardiac function to be eligible for surgical resection with curative intent
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Male participants must be willing to use acceptable methods of contraception
Female participants of childbearing potential must agree to use acceptable methods of contraception

Inclusion Criteria for Adjuvant Therapy

Participants whose tumors lack radiographic progression
ECOG Performance Status of 0 or 1
Adequate hematologic and end-organ function

Exclusion Criteria

NSCLC that is clinically T4 by virtue of mediastinal organ invasion or Stage IIIB by virtue of N3 disease
Any prior therapy for lung cancer, including chemotherapy, targeted therapy, immunotherapy, or radiotherapy, within 2 years
Participants with prior lung cancer that have been in remission for <2 years with the exception of minimally invasive adenocarcinoma or incidental typical carcinoid tumors
Major surgical procedure within 28 days prior to Cycle 1, Day 1
Participants known to be positive for HIV are excluded if they meet any of the following criteria: CD4+ T-cell count of <350 cellsmicroliters; detectable HIV viral load; history of an opportunistic infection within the past 12 months; on stable antiretroviral therapy for <4 weeks
Severe infection within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infections, or any active infection that, in the opinion of the investigator, could impact participant safety
Pregnant or lactating, or intending to become pregnant during the study

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

80

Study ID:

NCT04302025

Recruitment Status:

Recruiting

Sponsor:

Genentech, Inc.

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There are 25 Locations for this study

See Locations Near You

City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
USC Norris Cancer Center
Los Angeles California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
UCLA Hematology Oncology
Los Angeles California, 90095, United States
The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange
Orange California, 92868, United States
UC Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)
Washington District of Columbia, 20007, United States
Sylvester Comprehensive Cancer Center - Deerfield Beach
Miami Florida, 33136, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Dana-Farber Cancer Institute; Brigham and Women's Cancer Center
Boston Massachusetts, 02115, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Karmanos Cancer Institute - Farmington Hills/Weisberg Cancer Treatment Center
Farmington Hills Michigan, 48334, United States
University of Missouri Health Care; Ellis Fischel Cancer Center
Columbia Missouri, 65212, United States
HCA Midwest Health
Kansas City Missouri, 64132, United States
Washington University School of Medicine; Sitemann Cancer Center
Saint Louis Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
New York New York, 10016, United States
Columbia University Medical Center
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
Ohio State University; Hemat/Onc
Columbus Ohio, 43210, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

80

Study ID:

NCT04302025

Recruitment Status:

Recruiting

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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