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Monoclonal Antibodies

Amivantamab + TKI for Lung Cancer

Phase 1 & 2

Recruiting

Led By Patil Tejas, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Participant is ≥ 18 years of age

Participant has histologic or cytologic confirmation of locally advanced (unresectable) or metastatic NSCLC with a known (and documented) ALK, ROS1, or RET fusion based on approved diagnostic testing methods

Must not have

Participants with active, symptomatic, central nervous system disease

The participant has evidence of neuroendocrine differentiation or small cell transformation on the screening biopsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 40 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses drugs to treat lung cancer by blocking pathways that allow cancer to resist current drugs. This could help stop cancer cells from adapting and becoming resistant.

Who is the study for?

Adults with advanced NSCLC who have ALK, ROS1, or RET gene fusions and have seen their cancer progress after at least one TKI treatment. They must be currently on a stable dose of TKI for 3+ months, able to take oral meds, and have a life expectancy over 12 weeks. Excluded are those with certain prior treatments, active infections like HIV or hepatitis B/C, pregnant women, and anyone with severe allergies to study drugs.

What is being tested?

The trial is testing Amivantamab in combination with current TKI therapies against advanced non-small cell lung cancer (NSCLC) that has specific genetic alterations (ALK, ROS1, RET). The goal is to see if this combo can overcome resistance developed from previous treatments by inhibiting pathways that the cancer cells use to survive.

What are the potential side effects?

Amivantamab may cause side effects such as infusion reactions (like fever or chills), skin rash or itching. There's also a risk of developing conditions affecting the lungs like interstitial lung disease. Side effects vary among individuals.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My advanced lung cancer is confirmed to have ALK, ROS1, or RET fusion.

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I have been on the same TKI medication for at least 3 months due to my cancer progressing.

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I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

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

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I have active symptoms from a brain or spinal cord condition.

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My biopsy shows signs of neuroendocrine differentiation or small cell transformation.

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I have never been treated with specific targeted lung cancer drugs before joining this study.

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I have a history of interstitial lung disease.

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I have a serious bowel problem that affects my eating or nutrient absorption.

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I have been diagnosed with another type of cancer within the last 2 years.

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My cancer does not have ALK, ROS1, or RET gene changes.

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I have untreated, chronic hepatitis B.

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I do not have any uncontrolled illnesses that would interfere with the study.

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I have a rash from cancer immunotherapy that hasn't healed.

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My condition worsened within 3 months of starting a TKI treatment.

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I still have major side effects from cancer treatment that haven't improved.

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I have an ongoing, untreated hepatitis C infection.

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I have an ongoing heart condition.

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I currently have an untreated COVID-19 infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 40 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~40 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 40 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Determine the MTD in adult participants with advanced NSCLC

Estimate the objective response rate (ORR) of amivantamab in combination with common TKIs used in ALK, ROS1, and RET advanced NSCLC progressing on TKIs

Secondary study objectives

Collect treatment-emergent adverse events

Collect treatment-related adverse events (TRAEs)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose Finding (Safety Lead-In) Cohort (≥80 kg)Experimental Treatment1 Intervention

To estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) in adult participants with advanced NSCLC with ALK, ROS1, and RET gene fusions.

Group II: Dose Finding (Safety Lead-In) Cohort (<80 kg)Experimental Treatment1 Intervention

To estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) in adult participants with advanced NSCLC with ALK, ROS1, and RET gene fusions.

Group III: Dose Expansion Cohort (≥80 kg)Experimental Treatment1 Intervention

To estimate the objective response rate (ORR) of amivantamab in combination with common TKIs used in ALK, ROS1, and RET advanced NSCLC progressing on TKIs.

Group IV: Dose Expansion Cohort (<80 kg)Experimental Treatment1 Intervention

To estimate the objective response rate (ORR) of amivantamab in combination with common TKIs used in ALK, ROS1, and RET advanced NSCLC progressing on TKIs.

0 / 19Eligibility criteria met