Neoadjuvant KRAS G12C Directed Therapy With Adagrasib (MRTX849) With or Without Nivolumab

Conditions

• Resectable Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Adagrasib — DRUG
  Oral Adagrasib 600 mg twice daily for 6 weeks prior to surgery.
• Adagrasib/Nivolumab — COMBINATION_PRODUCT
  Oral Adagrasib 400 mg twice daily for 6 weeks and IV nivolumab 240mg every 2 weeks for 3 doses prior to surgery.

Study Details

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.

Key Dates

Start date

Mar 21, 2023

Status verified

Sep 2025

Primary completion

Jun 1, 2025

Completion

Sep 1, 2025

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A
  Arm A treatment: Oral Adagrasib 600 mg twice daily for 6 weeks prior to surgery. Surgical Resection, then standard postoperative therapy(chemo +/- RT).
• Active Comparator: Arm B
  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).

Primary Outcome Measure

Pathologic complete response (pCR) rate [ Time Frame: Within 90 days of surgery ]

Locations (1)

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