What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include EGFR inhibitors, chemotherapy, and immunotherapy. EGFR inhibitors, such as gefitinib, can cause side effects like rash, diarrhea, and liver function abnormalities. Chemotherapy agents, including carboplatin and paclitaxel, often lead to neutropenia, fatigue, nausea, and neuropathy. Immunotherapy, such as pembrolizumab, may result in immune-related adverse events like pneumonitis, colitis, and thyroid dysfunction. Each treatment has a unique side effect profile that should be discussed with a healthcare provider.

What prior FDA approvals exist?

Several EGFR inhibitors have received FDA approval for the treatment of Non-Small Cell Lung Cancer (NSCLC). Gefitinib and erlotinib were among the first EGFR tyrosine kinase inhibitors (TKIs) approved for NSCLC with EGFR mutations. Afatinib and osimertinib are other notable EGFR inhibitors approved for similar indications. These drugs target specific mutations in the EGFR gene, which are common in a subset of NSCLC patients, and have shown efficacy in improving progression-free survival and overall survival in clinical trials.

What other types of research exist?

Promising alternatives to CLN-081 for NSCLC patients include next-generation ALK inhibitors such as alectinib, brigatinib, and lorlatinib, which have shown efficacy in ALK-positive NSCLC. Additionally, pembrolizumab combined with chemotherapy has demonstrated improved overall survival in PD-L1-positive NSCLC. For EGFR mutation-positive NSCLC, osimertinib is a well-established option, and ongoing research is exploring combination therapies and new TKIs.

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Tyrosine Kinase Inhibitor

Zipalertinib for Non-Small Cell Lung Cancer (REZILIENT1 Trial)

Verified Trial

Phase 1 & 2

Waitlist Available

Research Sponsored by Cullinan Therapeutics Inc.

Eligibility Criteria Checklist

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

Must have

Are you able to carry out light work throughout your day?

Have you been diagnosed with advanced or metastatic non small cell lung cancer?

Must not have

Have you previously been treated with poziotinib, mobocertinib, amivantamab, DZD9008, or BDTX-189?

Do you currently smoke?

Timeline

Screening 28 days

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing CLN-081, a new drug, in patients with a specific type of lung cancer that has a genetic mutation. The drug aims to block a protein that helps cancer cells grow, to see if it can slow down or stop the cancer.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has a specific mutation called EGFR exon 20 insertion. Participants can be new to treatment or have had certain prior therapies, but not treatments targeting this specific mutation or CLN-081. They should be able to do light work and must not currently smoke or have used tobacco recently.

What is being tested?

The study is testing the safety and effectiveness of a drug named CLN-081 in patients with NSCLC who have the EGFR exon 20 insertion mutation. It's an early-stage trial aiming to find the best dose for Phase 2 and see how well it works against this type of lung cancer.

What are the potential side effects?

While side effects are being studied, potential risks may include typical reactions seen with cancer drugs such as fatigue, digestive issues, skin changes, blood disorders, and possibly effects on lung function given concerns about excluding those with past severe pneumonitis.

Eligibility Criteria

Inclusion Criteria

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

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I can do light work throughout the day.

Select...

I have advanced or metastatic non-small cell lung cancer.

Select...

My cancer has an EGFR ex20ins mutation.

Exclusion Criteria

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

Select...

I have not been treated with poziotinib, mobocertinib, amivantamab, DZD9008, or BDTX-189.

Timeline

Screening ~ 28 days1 visit

Treatment ~ Varies

Follow Up ~ 24 months1 visit

Screening ~ 28 days

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 28 days for screening, Varies for treatment, and 24 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

Module A: Pharmacokinetic (PK) parameter

Awards & Highlights

No Placebo-Only Group

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

Trial Design

6Treatment groups

Experimental Treatment

Group I: Phase 2a Dose Expansion(s)Experimental Treatment1 Intervention

CLN-081 BID in expansion cohorts that may be opened at doses that meet pre-specified efficacy and safety criteria.

Group II: Phase 1 Dose Escalation (Rolling Six)Experimental Treatment1 Intervention

CLN-081 BID in Rolling Six dose escalation cohorts enrolling NSCLC patients with EGFR exon 20 insertion mutations.

Group III: Phase 1 Dose Escalation (Accelerated Titration)Experimental Treatment1 Intervention

CLN-081 BID in single patient dose escalation cohorts enrolling NSCLC patients with EGFR exon 20 insertion mutations that either have received or never received prior EGFR TKIs.

Group IV: Module CExperimental Treatment1 Intervention

CLN-081 BID to patients with EGFR exon 20 insertion mutant NSCLC after prior therapy with an agent approved for the treatment of ex20ins mutant NSCLC.

Group V: Module BExperimental Treatment1 Intervention

CLN-081 BID in NSCLC patients with EGFR exon 20 insertion mutations that have received prior systemic therapy for locally advanced or metastatic disease.

Group VI: Module A Food AffectExperimental Treatment1 Intervention

Single-dose CLN-081 150 mg with and without high fat food intake.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include EGFR inhibitors, chemotherapy, and immunotherapy. EGFR inhibitors, like CLN-081, target mutations in the epidermal growth factor receptor (EGFR) gene, which are often present in NSCLC. By blocking the EGFR pathway, these inhibitors prevent cancer cell growth and proliferation. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect healthy cells, leading to side effects. Immunotherapy, such as PD-1/PD-L1 inhibitors, boosts the body's immune system to recognize and attack cancer cells. These treatments are crucial for NSCLC patients as they offer targeted and effective options, especially for those with specific genetic mutations like EGFR exon 20 insertions, improving outcomes and potentially extending survival.

New targeted treatments in lung cancer--overview of clinical trials.