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Small Molecule

Adagrasib +/- Nivolumab for Non-Small Cell Lung Cancer (Neo-Kan Trial)

Phase 2

Waitlist Available

Led By Kristen Marrone

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed diagnosis of NSCLC (squamous or nonsquamous) with KRAS G12C mutation

Age ≥18 years

Must not have

Prior systemic treatment for lung cancer including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation

Prior thoracic radiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 90 days of surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new cancer drug combo to see if it's safe and effective for patients with a certain type of lung cancer.

Who is the study for?

Adults over 18 with stage IB-IIIA non-small cell lung cancer (NSCLC) and a specific KRAS G12C mutation can join. They must be candidates for potential curative surgery, not pregnant or breastfeeding, willing to use contraception, and have no history of certain diseases or treatments that could interfere with the trial.

What is being tested?

The trial is testing Adagrasib alone or combined with Nivolumab in patients before surgery to see if it's safe and effective. It's an open-label phase 2 study which means everyone knows what treatment they're getting.

What are the potential side effects?

Possible side effects include typical reactions from cancer therapies such as fatigue, nausea, liver enzyme changes, and immune-related conditions due to Nivolumab potentially affecting normal cells while targeting cancer.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is confirmed to have a KRAS G12C mutation.

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I am 18 years old or older.

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My biopsy was reviewed by a specialist and tissue is available for more tests.

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My blood and organ tests are within normal ranges for surgery.

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My cancer has a KRAS G12C mutation.

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My breast cancer is at a specific stage and has not spread to distant lymph nodes.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had treatments like chemotherapy or immunotherapy for lung cancer.

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I have had radiation therapy to the chest area before.

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My lung cancer cannot be removed by surgery.

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You have had a heart attack, unstable angina, or serious heart failure in the last 6 months, or you have certain heart rhythm problems or a prolonged QT interval. You also have conditions that may affect how the study drug works or affect your ability to absorb oral medications.

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I have had brain scans before joining this study.

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I have had a bone marrow transplant or have a primary immune system disorder.

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I am not pregnant or nursing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 90 days of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 90 days of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 90 days of surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathologic complete response (pCR) rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Arm AActive Control1 Intervention

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

Group II: Arm BActive Control1 Intervention

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).

0 / 14Eligibility criteria met