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Monoclonal Antibodies

NVL-655 for NSCLC

Phase 1 & 2
Recruiting
Research Sponsored by Nuvalent Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Cohort 2d: histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-3 years after first patient dosed
Awards & highlights

Study Summary

This trial is a Phase 1/2 study to test the safety and effectiveness of NVL-655 in patients with advanced ALK-positive non-small cell lung cancer or other solid tumors.

Who is the study for?
This trial is for adults with advanced solid tumors, especially non-small cell lung cancer (NSCLC), that have changes in a gene called ALK. Kids over 12 and weighing more than 40 kg can join one part of the study. Participants need to have measurable disease and good organ function but can't be on other cancer treatments or have allergies to NVL-655 components.Check my eligibility
What is being tested?
NVL-655 is being tested in two phases: Phase 1 finds the safest dose by slowly increasing it, while Phase 2 tests how well this dose works using measures like tumor shrinkage rate, how long patients respond, survival without disease getting worse, overall survival time, and total benefit rate.See study design
What are the potential side effects?
While specific side effects of NVL-655 are not listed here, similar drugs often cause tiredness, nausea, diarrhea or constipation; blood count changes leading to infection risk; liver or kidney issues; and sometimes allergic reactions during infusion.

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 cancer is advanced or has spread, and tests show an ALK gene change.
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My advanced lung cancer has a specific genetic change known as ALK rearrangement.
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My cancer is advanced or has spread, and tests show an ALK gene change.
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My advanced lung cancer has a confirmed ALK gene change.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-3 years after first patient dosed
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-3 years after first patient dosed for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicities (DLTs) (Phase 1)
Number of participants with treatment-emergent adverse events, as assessed by CTCAE, V5.0 (Phase 1)
Objective Response Rate (ORR) (Phase 2)
+1 more
Secondary outcome measures
Area under the curve at the end of the dosing interval (AUCtau) of NVL-655
Area under the curve from time 0 to 24 (AUC0-24) of NVL-655
Area under the curve from time 0 to infinity (AUCinf) of NVL-655
+15 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: Phase 1 dose escalationExperimental Treatment1 Intervention
NVL-655 oral daily dosing
Group II: Cohort 2fExperimental Treatment1 Intervention
Patients with other solid tumors harboring an ALK rearrangement or activating ALK mutation, who have received ≥1 prior systemic anticancer therapy, or for whom no satisfactory standard therapy exists.
Group III: Cohort 2eExperimental Treatment1 Intervention
Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, not eligible for other Phase 2 cohorts.
Group IV: Cohort 2dExperimental Treatment1 Intervention
Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who are naïve to ALK TKI therapy. Up to one prior line of chemotherapy and/or immunotherapy is allowed.
Group V: Cohort 2cExperimental Treatment1 Intervention
Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who have received lorlatinib as the only prior ALK TKI therapy. Up to one prior line of chemotherapy and/or immunotherapy received prior to lorlatinib is allowed.
Group VI: Cohort 2bExperimental Treatment1 Intervention
Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who have received 2-3 prior ALK TKIs (crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib). Up to 2 prior lines of chemotherapy and/or immunotherapy are allowed.
Group VII: Cohort 2aExperimental Treatment1 Intervention
Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received 1 prior 2nd-generation ALK TKI (ceritinib, alectinib, or brigatinib). Up to 2 prior lines of chemotherapy and/or immunotherapy are allowed.

Find a Location

Who is running the clinical trial?

Nuvalent Inc.Lead Sponsor
1 Previous Clinical Trials
359 Total Patients Enrolled
Viola Zhu, MD, PHDStudy DirectorNuvalent Inc.

Media Library

NVL-655 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05384626 — Phase 1 & 2
Solid Tumors Research Study Groups: Cohort 2e, Cohort 2f, Cohort 2c, Cohort 2d, Phase 1 dose escalation, Cohort 2a, Cohort 2b
Solid Tumors Clinical Trial 2023: NVL-655 Highlights & Side Effects. Trial Name: NCT05384626 — Phase 1 & 2
NVL-655 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05384626 — Phase 1 & 2
Solid Tumors Patient Testimony for trial: Trial Name: NCT05384626 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it still possible to register for participation in this experiment?

"According to the clinicaltrials.gov database, this investigation is currently in its recruitment stage. Its presence on the site was first registered on June 9th 2022 and it most recently underwent an update on November 1st 2022."

Answered by AI

What goal is this experiment attempting to achieve?

"This clinical trial seeks to discover the Recommended Phase 2 Dose (RP2D) within 21 days of initial NVL-655 dosage. Secondary objectives involve calculating Average plasma concentration (Cavg), Overall survival (OS), and Duration of response (DOR). This data will be collected until radiographic progression or death is observed."

Answered by AI

How many locations are currently offering this trial to participants?

"Currently, 7 medical sites are offering this clinical trial including University of Colorado Cancer Center in Denver, Mass General Hospital in Boston, and MD Anderson Cancer Centre in Houston. Additionally, there are 4 other locations participating."

Answered by AI

What is the participant count for this clinical experiment?

"Affirmative. Clinicaltrials.gov's records reveal that this medical trial, first posted on June 9th 2022, is currently recruiting patients. 214 individuals are needed across 7 locations for the study to be successful."

Answered by AI

Who else is applying?

How old are they?
65+
What site did they apply to?
Sarah Cannon
Fred Hutchinson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
What state do they live in?
Washington
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Looking for alternative treatment.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
2022. "A Study of NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05384626.
~230 spots leftby Feb 2026
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