Lung cancer drug combo trial pulled before it began
NCT ID NCT05472623
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study planned to test a targeted cancer pill (adagrasib) alone or with an immunotherapy drug (nivolumab) before surgery in people with a specific type of lung cancer (KRAS G12C mutation). The goal was to see if these drugs could eliminate all cancer cells by the time of surgery. However, the trial was withdrawn before enrolling any participants, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Adagrasib (a targeted cancer pill) with or without nivolumab (an immunotherapy drug)
- What this could lead to
- If successful, this approach could shrink lung tumors before surgery, potentially improving outcomes for people with KRAS G12C mutations.
- What could go wrong
- The trial was withdrawn before enrolling any participants, so no data is available. It is unclear if the combination would be safe or effective.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Started
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Mar 2023
- Finished
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Sep 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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
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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 Hide 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: * Age ≥18 years * Histologically confirmed diagnosis of NSCLC (squamous or nonsquamous) with KRAS G12C mutation. * Diagnostic core biopsy specimens must be reviewed by a faculty pathologist at the enrolling/treating institution, and biopsy tissue must be available for further biomarker evaluation. If no archived tissue is available, patients will require a repeat biopsy prior to initiation of study treatment. See section 6.5.1 and lab manual for details of pretreatment biopsy tissue required. * KRAS G12C mutation determined by any CLIA-certified testing platform on patient tumor tissue or plasma sample. * Stage IB-IIIA NSCLC * T2aN0, T3N0, T1-2N1, T3-4N1, T1-2N2. This includes T2aN0 tumors ≥3 cm. Subjects with N3 nodal involvement are not included. * Primary resection option for potential cure as assessed by a faculty surgeon at treating institution. * ECOG performance status 0-1 (See Appendix B) * Adequate organ function within the screening period as follows: * Leukocytes ≥ 2,000/mm3 * Absolute neutrophil count (ANC) ≥ 1000/mm3 * Platelet count ≥ 100,000/mm3 * Hemoglobin ≥ 9 g/dL * Creatinine ≤ 1.5 x institutional upper limit of normal (ULN) or creatinine clearance (CrCl) ≥60 mL/min * Total Bilirubin ≤ 1.5 x institutional ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL) * AST(SGOT), ALT(SGPT), and alkaline phosphatase ≤ 3 x institutional ULN * Pulmonary Function Testing to include DLCO must be performed to determine feasibility of surgical resection. * Women of child-bearing potential (WOCBP): * Agree to use contraception while participating in this study, and for a period of 6 months following last dose of Adagrasib or nivolumab, as effects of these agents on the developing human fetus are unknown. Men whose partner is a WOCBP must also agree to use contraception during this period. * Negative pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within two weeks of registration. * Women must not be breastfeeding or plan to breastfeed for the duration of therapy or 6 months after. * Completed informed consent process, including signing IRB/EC-approved informed consent form. * Willing and able to comply with clinical trial instructions and requirements. Subjects must be competent to report AEs, understand the drug dosing schedule, and use of medications to control AEs. Exclusion Criteria: * Patients presenting with any of the following will not be included in the study: * NSCLC not amenable to curative intent resection based on evaluation by faculty surgeon at treating institution. * This includes any patient with pathologically confirmed N3 disease. * Prior systemic treatment for lung cancer including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation. * Prior thoracic radiation. * Any concurrent malignancies for which active therapy is being received. * Exceptions: non-melanoma skin cancers; in situ dysplasia of the bladder, gastric, breast, colon, or cervix * Brain metastases at time of screening. * All patients must have brain imaging prior to enrollment (MRI brain or CT brain with contrast preferred). * Active or prior documented autoimmune or inflammatory disease as follows (Arm B only): * Medically relevant autoimmune disease requiring systemic treatment within 2 years prior to the first dose of study treatment. * Systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration (Arm B only). Inhaled or topical steroids are permitted. * Adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. * Major surgery within 4 weeks prior to first dose of study treatment. * History of allogeneic transplant or primary immunodeficiency. * Uncontrolled human immunodeficiency virus (HIV) infection or acute or chronic hepatitis B or C infection. * Patients treated for hepatitis C with no detectable viral load and patients treated for HIV with no detectable viral load for at least 1 month while on a stable regimen of agents that are not strong inhibitors of CYP3A4 are permitted. * HIV testing is not required in absence of clinical suspicion of HIV. * Any of the following cardiac abnormalities: * Unstable angina pectoris or myocardial infarction within the past 6 months. * Symptomatic or uncontrolled atrial fibrillation within the past 6 months. * Congestive heart failure ≥NYHA Class 3 within the past 6 months. * QTc ≥ 480 msec in screening ECG measured using standard institutional method or history of familial long QT syndrome. * Ongoing need for a medication with any of the following characteristics that cannot be switched to alternative treatment prior to study entry (see Appendix D): known risk of Torsades de Pointes; substrate of CYP3A with narrow therapeutic index; strong inducer or inhibitor of CYP3A and/or P-gp; strong inhibitor of BCRP; and proton pump inhibitors. * History of stroke or transient ischemic attack within 6 months prior to first dose of study treatment. * History of intestinal disease or major gastric surgery likely to alter absorption of study treatment or inability to swallow oral medications. * Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events. * Women who are pregnant or nursing. * Prisoners or subjects who are involuntarily incarcerated or compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness. * Receipt of a live vaccine within 30 days prior to first dose of study treatment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Johns Hopkins
Baltimore, Maryland, 21231, United States
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Other studies related to the condition(s) this trial covers.
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