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New hope for lung cancer: personalized drug cocktails before surgery

NCT ID NCT04302025

Disease control Sponsor: Genentech, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 6 times

Summary

This study tests different drug combinations in people with early-stage non-small cell lung cancer that can be removed with surgery. The drugs are chosen based on specific genetic markers in each person's tumor. The goal is to see if these treatments shrink the tumor before surgery and help prevent the cancer from coming back afterward. About 99 participants will receive therapy before and after their operation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 99 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2020

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria for Neoadjuvant Therapy: * Pathologically documented NSCLC: * Newly diagnosed early-stage NSCLC stages IB, IIA, IIB, IIIA, or selected IIIB (T3N2 only) NSCLC of squamous or non-squamous histology. Staging should be based on the 8th edition of the American Joint Committee on Cancer (AJCC)/Union Internationale Contre le Cancer (UICC) NSCLC staging system * T4 primary NSCLC will be allowed only on the basis of size. Invasion of the diaphragm, mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, carina, and separate tumor nodules in a different ipsilateral lobe is not permitted * All participants will undergo clinical staging using computed tomography (CT) and positron emission tomography (PET) scanning, as well as brain imaging using magnetic resonance imaging (MRI). Invasive mediastinal staging by either mediastinoscopy or endo-bronchial ultrasonography is highly encouraged for participants with radiographically suspected mediastinal nodal disease (i.e., N2) but not mandated if the CT or PET scans showed no evidence of N2 disease * Molecular testing results from clinical laboratory improvement amendments (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 Food and Drug Administration (FDA)-approved test, KRAS G12C mutation * Measurable disease, as defined by RECIST v1.1 * NSCLC must have a solid or subsolid appearance on CT scan and cannot have a purely ground glass opacity appearance. For subsolid lesions, the tumor size (i.e., clinical T stage) should be measured based on the solid component only, exclusive of the ground glass opacity component * 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 * Adequate hematologic and end-organ function * Negative hepatitis B surface antigen (HBsAg) test at screening for cohort * Negative total hepatitits B core antibody (HBcAb) test at screening for cohort, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) deoxyribonucleic acid (DNA) test at screening * Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening * 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 (TKI Cohorts and KRAS G12C cohort \[if continuing on Divarasib\]): * 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 * Major surgical procedure within 28 days prior to Cycle 1, Day 1 * Malignancies other than the disease under study within 3 years prior to Cycle 1, Day 1, with the exception of participants with a negligible risk of metastasis or death and with expected curative outcome * Treatment with an investigational agent for any condition within 4 weeks prior to Cycle 1, Day 1 * Participants known to be positive for human immunodeficiency virus (HIV) are excluded if they meet any of the following criteria: cluster of differentiation 4 (CD4)+ T-cell count of \<350 cells/microliters (cells/µL); 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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    23 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AHN Cancer Institute ? Allegheny General Hospital

    COMPLETED

    Pittsburgh, Pennsylvania, 15212, United States

  • Baptist Clinical Research Institute

    RECRUITING

    Memphis, Tennessee, 38120, United States

  • Baylor College of Medicine

    WITHDRAWN

    Houston, Texas, 77030, United States

  • Boston Medical Center

    WITHDRAWN

    Boston, Massachusetts, 02118, United States

  • Cedars-Sinai Medical Center

    WITHDRAWN

    Los Angeles, California, 90048, United States

  • City of Hope - Orange County Lennar Foundation Cancer Center

    WITHDRAWN

    Irvine, California, 92618, United States

  • City of Hope Comprehensive Cancer Center

    WITHDRAWN

    Duarte, California, 91010, United States

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Dartmouth Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Ellis Fischel Cancer Center

    RECRUITING

    Columbia, Missouri, 65201, United States

  • Karmanos Cancer Institute - Farmington Hills/Weisberg Cancer Treatment Center

    WITHDRAWN

    Farmington Hills, Michigan, 48334, United States

  • Kelsey Seybold Clnic

    WITHDRAWN

    Houston, Texas, 77025, United States

  • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

    RECRUITING

    New York, New York, 10016, United States

  • Lumi Research

    WITHDRAWN

    Kingwood, Texas, 77339, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)

    RECRUITING

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

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Northwestern Medicine Cancer Center Delnor

    RECRUITING

    Geneva, Illinois, 60134, United States

  • Northwestern Medicine Cancer Center Kishwaukee

    RECRUITING

    DeKalb, Illinois, 60115, United States

  • Northwestern Medicine Cancer Center Warrenville

    RECRUITING

    Warrenville, Illinois, 60555, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Seattle Cancer Care Alliance

    WITHDRAWN

    Seattle, Washington, 98109, United States

  • Siteman Cancer Center - Washington University Medical Campus

    RECRUITING

    St Louis, Missouri, 63108, United States

  • Tennessee Oncology - Nashville

    WITHDRAWN

    Nashville, Tennessee, 37203, United States

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

    RECRUITING

    Orange, California, 92868, United States

  • UC Davis Comprehensive Cancer Center

    RECRUITING

    Sacramento, California, 95817, United States

  • UCSF Helen Diller Family CCC

    WITHDRAWN

    San Francisco, California, 94158, United States

  • USC Norris Cancer Center

    WITHDRAWN

    Los Angeles, California, 90033, United States

  • University Hospitals Cleveland Medical Center

    WITHDRAWN

    Cleveland, Ohio, 44016, United States

  • University of California Los Angeles - Jonsson Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90095, United States

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

    WITHDRAWN

    Aurora, Colorado, 80045, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030-4008, United States

  • Virginia Cancer Specialists (Fairfax) - USOR

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06511, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.