Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04302025

A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)

Led by Genentech, Inc. · Updated on 2026-04-03

99

Participants Needed

38

Research Sites

498 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial will evaluate the efficacy and safety of various therapies in participants with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated NSCLC tumors that meet protocol-specified biomarker criteria.

CONDITIONS

Official Title

A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically confirmed non-small cell lung cancer (NSCLC) stages IB, IIA, IIB, IIIA, or selected IIIB (T3N2 only) based on AJCC/UICC 8th edition staging
  • Tumors must have specific biomarker abnormalities including ALK, ROS1, NTRK fusions; BRAF V600 mutation; RET fusion; PD-L1 expression 61% tumor cells; or KRAS G12C mutation
  • Measurable disease by RECIST v1.1 criteria
  • Tumors must appear solid or subsolid on CT scan, not purely ground glass opacity
  • Surgeon evaluation confirming that tumor and lymph nodes can be completely removed and participant is medically operable
  • Adequate lung and heart function for surgery
  • ECOG Performance Status 0 or 1
  • Adequate blood and organ function
  • Negative hepatitis B surface antigen and core antibody, or negative HBV DNA if core antibody positive
  • Negative hepatitis C antibody or negative HCV RNA if antibody positive
  • Male participants must agree to use acceptable contraception
  • Female participants of childbearing potential must agree to use acceptable contraception
  • For adjuvant therapy: no tumor progression, ECOG 0 or 1, adequate blood and organ function
Not Eligible

You will not qualify if you...

  • NSCLC classified as T4 due to invasion of mediastinal organs or Stage IIIB with N3 disease
  • Prior lung cancer therapy within 2 years including chemotherapy, targeted therapy, immunotherapy, or radiotherapy
  • Previous lung cancer diagnosis
  • Major surgery within 28 days before starting study treatment
  • Other cancers within 3 years except low-risk or cured cases
  • Treatment with any investigational drug within 4 weeks before start
  • HIV positive with CD4+ count <350 cells/bcl, detectable viral load, recent opportunistic infection, or short antiretroviral therapy
  • Severe infection requiring hospitalization within 4 weeks before treatment
  • Pregnant, breastfeeding, or planning pregnancy during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 38 locations

1

City of Hope Comprehensive Cancer Center

Duarte, California, United States, 91010

Withdrawn

2

City of Hope - Orange County Lennar Foundation Cancer Center

Irvine, California, United States, 92618

Withdrawn

3

USC Norris Cancer Center

Los Angeles, California, United States, 90033

Withdrawn

4

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Withdrawn

5

University of California Los Angeles - Jonsson Comprehensive Cancer Center

Los Angeles, California, United States, 90095

Actively Recruiting

6

The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange

Orange, California, United States, 92868

Actively Recruiting

7

UC Davis Comprehensive Cancer Center

Sacramento, California, United States, 95817

Actively Recruiting

8

UCSF Helen Diller Family CCC

San Francisco, California, United States, 94158

Withdrawn

9

University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)

Aurora, Colorado, United States, 80045

Withdrawn

10

Yale Cancer Center

New Haven, Connecticut, United States, 06511

Actively Recruiting

11

MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)

Washington D.C., District of Columbia, United States, 20007

Actively Recruiting

12

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Actively Recruiting

13

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

14

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States, 60115

Actively Recruiting

15

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States, 60134

Actively Recruiting

16

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States, 60555

Actively Recruiting

17

Boston Medical Center

Boston, Massachusetts, United States, 02118

Withdrawn

18

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

19

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

20

Karmanos Cancer Institute - Farmington Hills/Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States, 48334

Withdrawn

21

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

22

Ellis Fischel Cancer Center

Columbia, Missouri, United States, 65201

Actively Recruiting

23

Siteman Cancer Center - Washington University Medical Campus

St Louis, Missouri, United States, 63108

Actively Recruiting

24

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

25

Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

New York, New York, United States, 10016

Actively Recruiting

26

Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

27

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

28

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44016

Withdrawn

29

Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

30

AHN Cancer Institute ? Allegheny General Hospital

Pittsburgh, Pennsylvania, United States, 15212

Completed

31

Baptist Clinical Research Institute

Memphis, Tennessee, United States, 38120

Actively Recruiting

32

Tennessee Oncology - Nashville

Nashville, Tennessee, United States, 37203

Withdrawn

33

Kelsey Seybold Clnic

Houston, Texas, United States, 77025

Withdrawn

34

University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030-4008

Actively Recruiting

35

Baylor College of Medicine

Houston, Texas, United States, 77030

Withdrawn

36

Lumi Research

Kingwood, Texas, United States, 77339

Withdrawn

37

Virginia Cancer Specialists (Fairfax) - USOR

Fairfax, Virginia, United States, 22031

Actively Recruiting

38

Seattle Cancer Care Alliance

Seattle, Washington, United States, 98109

Withdrawn

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Research Team

R

Reference Study ID Number: ML41591 https://forpatients.roche.com/

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

7

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A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC) | DecenTrialz