Resectable Non-Small Cell Lung CancerPhase 2Neo-KanNCT05472623
Neoadjuvant KRAS G12C Directed Therapy With Adagrasib (MRTX849) With or Without Nivolumab
A Phase 2 study testing Adagrasib and Adagrasib/Nivolumab in people with Resectable Non-Small Cell Lung Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This is an open label phase 2 clinical trial evaluating the clinical safety, feasibility and efficacy of neoadjuvant Adagrasib alone or in combination with nivolumab in patients with NSCLC with KRAS G12C mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Non-Small Cell Lung Cancer
- What is being tested?
- Adagrasib and Adagrasib/Nivolumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2023to 1 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Trial of Neoadjuvant KRAS G12C Directed Therapy With Adagrasib (MRTX849) With or Without Nivolumab in Resectable Non-Small Cell Lung Cancer (Neo-KAN)
This is an open label phase 2 clinical trial evaluating the clinical safety, feasibility and efficacy of neoadjuvant Adagrasib alone or in combination with nivolumab in patients with NSCLC with KRAS G12C mutation.
Read the detailed description
Approximately 30% of patients with non-small cell lung cancer (NSCLC) present with resectable disease, but following surgery, the majority will experience relapse and death from the cancer. Despite significant advances in therapy for advanced NSCLC, no new systemic neoadjuvant therapies have been approved for resectable NSCLC without an EGFR driver mutation in over 15 years, and these patients are in critical need of new treatments to improve rates of cure. Currently, the standard approach for resectable stage II and III disease is 3-4 cycles of pre- or postoperative chemotherapy, which provides an absolute 5-year survival benefit of only 5% over surgery alone.
Neoadjuvant systemic therapy provides an opportunity to improve outcomes with surgery at a similar rate to adjuvant therapy, and is a more useful platform for advancing the development of new targeted and combination therapies. Pathologic complete response (pCR) and major pathologic response (MPR, ≤10% residual viable tumor) in the resected specimen serve as surrogate endpoints for event-free and overall survival, and are useful early efficacy endpoints to accelerate drug development. In resectable NSCLC, the rates of pCR and MPR with neoadjuvant immunotherapy alone are about 10% and 45% as compared to 4% and 20% with current standard of care chemotherapy. The recent approval of osimertinib in resected EGFR-mutated NSCLC has demonstrated the efficacy of targeted therapy in resectable disease, but is only available to a small minority of NSCLC patients.
KRAS is the most commonly mutated oncogene in cancer representing a vast unmet clinical need, particularly in NSCLC where it is associated with smoking history and mutated in 30% of lung adenocarcinomas. Activating KRAS mutations promote signaling pathways for growth, survival and differentiation. The most common mutant allele is KRAS G12C, present in 1 in 8 patients with NSCLC (12.5%), and represents an aggressive NSCLC phenotype with significantly higher risk of recurrence following resection in stage I-III disease.
Adagrasib is a novel small molecule inhibitor of KRAS G12C producing potent inhibition of KRAS-dependent signal transduction with high selectivity. Adagrasib has shown promise in advanced NSCLC, with 45% confirmed objective response rate and 96% disease control rate in the phase 1/2 KRYSTAL study.
Finally, the investigators anticipate enhanced efficacy of Adagrasib in combination with immune checkpoint blockade. Emerging clinical data suggests that Adagrasib reconditions the tumor immune microenvironment to become more immune-sensitive (e.g. in immune "cold" STK11 co-mutated tumors), and combination treatment with anti-PD-1 therapy resulted in increased durable responses compared to either agent alone in a murine model. Adagrasib is well-tolerated and has been safely combined with anti-PD1 therapy in a phase I trial. This will be the first study to bring this combination forward in resectable lung cancer.
This phase 2 clinical trial investigates the role of targeted KRAS G12C inhibition with and without the anti-PD-1 agent nivolumab in resectable NSCLC
- Conditions
- Resectable Non-Small Cell Lung Cancer
- Being tested
- Adagrasib, Adagrasib/Nivolumab
- Keywords
- Adagrasib, Nivolumab, Neoadjuvant, Resectable, NSCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdagrasibDrug
Oral Adagrasib 600 mg twice daily for 6 weeks prior to surgery.
Adagrasib/NivolumabCombination product
Oral Adagrasib 400 mg twice daily for 6 weeks and IV nivolumab 240mg every 2 weeks for 3 doses prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Arm A treatment: Oral Adagrasib 600 mg twice daily for 6 weeks prior to surgery. Surgical Resection, then standard postoperative therapy(chemo +/- RT). Receives: Drug: Adagrasib |
| Arm B | Active comparator | Arm B treatment: Oral Adagrasib 400 mg twice daily for 6 weeks and IV Nivolumab 240mg every 2 weeks for 3 doses prior to surgery. Surgical Resection, then standard postoperative therapy(chemo +/- RT). Receives: Combination Product: Adagrasib/Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response (pCR) rate
Number of patients with absence of any residual viable tumor (0%) as determined by pathologic review of surgical resection specimens divided by total number of patients in each arm started on investigational therapy.
Measured: Within 90 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start21 Mar 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Sep 2025
Why it stopped: no participants enrolled across sites
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resectable Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study will enroll patients with newly diagnosed, biopsy-proven stage IB-IIIA NSCLC deemed surgically resectable and fit for surgery by a multidisciplinary thoracic oncology team. The study will accrue 42 patients to the following two arms sequentially: * Arm A: oral Adagrasib 600 mg twice daily for 6 weeks prior to surgery (21 patients) * Arm B: oral Adagrasib 400 mg twice daily for 6 weeks and IV nivolumab 240 mg every 2 weeks for 3 doses prior to surgery (21 patients)
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Mirati Therapeutics Inc., Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Kristen Marrone, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472623
- Sponsor's protocol ID
- IRB00306149
- Acronym
- Neo-Kan
- Status last verified
- Sep 2025
- First submitted
- 21 Jul 2022
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luo J, Florez N, Donnelly A, Lou Y, Lu K, Ma PC, Spira AI, Ryan D, Husain H. Adagrasib Treatment After Sotorasib-Related Hepatotoxicity in Patients With KRASG12C-Mutated Non-Small Cell Lung Cancer: A Case Series and Literature Review. JCO Precis Oncol. 2024 Apr;8:e2300644. doi: 10.1200/PO.23.00644.
PubMed 38579193
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial of Neoadjuvant KRAS G12C Directed Therapy With Adagrasib (MRTX849) With or Without Nivolumab in Resectable Non-Small Cell Lung Cancer (Neo-KAN)
- ClinicalTrials.gov ID
- NCT05472623
- Acronym / sponsor ID
- Neo-Kan / IRB00306149
- Conditions
- Resectable Non-Small Cell Lung Cancer
- Keywords
- Adagrasib, Nivolumab, Neoadjuvant, Resectable, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled across sites
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Mirati Therapeutics Inc., Bristol-Myers Squibb
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label phase 2 clinical trial evaluating the clinical safety, feasibility and efficacy of neoadjuvant Adagrasib alone or in combination with nivolumab in patients with NSCLC with KRAS G12C mutation.
Detailed description
Approximately 30% of patients with non-small cell lung cancer (NSCLC) present with resectable disease, but following surgery, the majority will experience relapse and death from the cancer. Despite significant advances in therapy for advanced NSCLC, no new systemic neoadjuvant therapies have been approved for resectable NSCLC without an EGFR driver mutation in over 15 years, and these patients are in critical need of new treatments to improve rates of cure. Currently, the standard approach for resectable stage II and III disease is 3-4 cycles of pre- or postoperative chemotherapy, which provides an absolute 5-year survival benefit of only 5% over surgery alone.
Neoadjuvant systemic therapy provides an opportunity to improve outcomes with surgery at a similar rate to adjuvant therapy, and is a more useful platform for advancing the development of new targeted and combination therapies. Pathologic complete response (pCR) and major pathologic response (MPR, ≤10% residual viable tumor) in the resected specimen serve as surrogate endpoints for event-free and overall survival, and are useful early efficacy endpoints to accelerate drug development. In resectable NSCLC, the rates of pCR and MPR with neoadjuvant immunotherapy alone are about 10% and 45% as compared to 4% and 20% with current standard of care chemotherapy. The recent approval of osimertinib in resected EGFR-mutated NSCLC has demonstrated the efficacy of targeted therapy in resectable disease, but is only available to a small minority of NSCLC patients.
KRAS is the most commonly mutated oncogene in cancer representing a vast unmet clinical need, particularly in NSCLC where it is associated with smoking history and mutated in 30% of lung adenocarcinomas. Activating KRAS mutations promote signaling pathways for growth, survival and differentiation. The most common mutant allele is KRAS G12C, present in 1 in 8 patients with NSCLC (12.5%), and represents an aggressive NSCLC phenotype with significantly higher risk of recurrence following resection in stage I-III disease.
Adagrasib is a novel small molecule inhibitor of KRAS G12C producing potent inhibition of KRAS-dependent signal transduction with high selectivity. Adagrasib has shown promise in advanced NSCLC, with 45% confirmed objective response rate and 96% disease control rate in the phase 1/2 KRYSTAL study.
Finally, the investigators anticipate enhanced efficacy of Adagrasib in combination with immune checkpoint blockade. Emerging clinical data suggests that Adagrasib reconditions the tumor immune microenvironment to become more immune-sensitive (e.g. in immune "cold" STK11 co-mutated tumors), and combination treatment with anti-PD-1 therapy resulted in increased durable responses compared to either agent alone in a murine model. Adagrasib is well-tolerated and has been safely combined with anti-PD1 therapy in a phase I trial. This will be the first study to bring this combination forward in resectable lung cancer.
This phase 2 clinical trial investigates the role of targeted KRAS G12C inhibition with and without the anti-PD-1 agent nivolumab in resectable NSCLC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will enroll patients with newly diagnosed, biopsy-proven stage IB-IIIA NSCLC deemed surgically resectable and fit for surgery by a multidisciplinary thoracic oncology team. The study will accrue 42 patients to the following two arms sequentially: * Arm A: oral Adagrasib 600 mg twice daily for 6 weeks prior to surgery (21 patients) * Arm B: oral Adagrasib 400 mg twice daily for 6 weeks and IV nivolumab 240 mg every 2 weeks for 3 doses prior to surgery (21 patients)
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: AdagrasibArm A treatment: Oral Adagrasib 600 mg twice daily for 6 weeks prior to surgery. Surgical Resection, then standard postoperative therapy(chemo +/- RT). |
| Arm B | Active comparator | Combination Product: Adagrasib/NivolumabArm B treatment: Oral Adagrasib 400 mg twice daily for 6 weeks and IV Nivolumab 240mg every 2 weeks for 3 doses prior to surgery. Surgical Resection, then standard postoperative therapy(chemo +/- RT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Age ≥18 years
- Histologically confirmed diagnosis of NSCLC (squamous or nonsquamous) with KRAS G12C mutation.
- Stage IB-IIIA NSCLC
- Primary resection option for potential cure as assessed by a faculty surgeon at treating institution.
- ECOG performance status 0-1 (See Appendix B)
Key exclusion criteria (30 listed)
- Patients presenting with any of the following will not be included in the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdagrasibOral Adagrasib 600 mg twice daily for 6 weeks prior to surgery. | Drug | Arm A |
| Adagrasib/NivolumabOral Adagrasib 400 mg twice daily for 6 weeks and IV nivolumab 240mg every 2 weeks for 3 doses prior to surgery. | Combination product | Arm B |
Primary outcome
Pathologic complete response (pCR) rate
Time frame: Within 90 days of surgery
Number of patients with absence of any residual viable tumor (0%) as determined by pathologic review of surgical resection specimens divided by total number of patients in each arm started on investigational therapy.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Derived from this study: PubMed 38579193Luo J, Florez N, Donnelly A, Lou Y, Lu K, Ma PC, Spira AI, Ryan D, Husain H. Adagrasib Treatment After Sotorasib-Related Hepatotoxicity in Patients With KRASG12C-Mutated Non-Small Cell Lung Cancer: A Case Series and Literature Review. JCO Precis Oncol. 2024 Apr;8:e2300644. doi: 10.1200/PO.23.00644.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen Marrone principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adagrasib and Adagrasib/Nivolumab in people with Resectable Non-Small Cell Lung Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response (pCR) rate (time frame: Within 90 days of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05472623, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.