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Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC

Sponsored by CatalYm GmbH

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Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Feb 27, 2026

Phase

Clinical Trial

Sponsor

CatalYm GmbH

Enrollment Target

107

Start Date

Aug 2025

πŸ“Š
1 of 107 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This is an exploratory, signal finding, randomized, placebo-controlled, blinded, multi-center Phase 2b trial of the anti GDF-15 antibody Visugromab (CTL-002) versus Placebo, combined with Immunochemotherapy (ICT: Pembrolizumab, Pemetrexed, Carboplatin) in the first-line treatment of participants with newly diagnosed metastatic non-squamous NSCLC. The trial consists of 3 Parts, a non-randomized Safety-run-in part (Part A) and the subsequent randomized Ph2b trial with 2 treatment arms.

Who Can Participate

Inclusion Criteria

Histologically confirmed, newly diagnosed stage IV non-squamous NSCLC.
Demonstrated absence of actionable mutations (e.g., EGFR, ALK, among others) that suggest/require treatment with available targeted agent.
Measurable disease determined by the local site Investigator/radiology by their assessment per RECIST v1.1.
Have not received prior systemic treatment for advanced/metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease and did not contain any PD 1/PD L1 directed CPI therapy.
Availability of locally determined PD L1 TPS, determined with a test validated for this purpose, from a biopsy obtained after any potential prior systemic treatment for this disease. Participants with PD-L1 TPS β‰₯ 50% can only be enrolled in case CPI monotherapy is not clinically indicated.
Availability of a tissue/histologic

❓ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

πŸ“‹

Study Type

INTERVENTIONAL

πŸ‘₯

Target Enrollment

107 participants

⚧

Gender

ALL

🏒

Sponsor

CatalYm GmbH

Study Locations

Choose your preferred location or select flexible during enrollment

NOT_YET_RECRUITING

Birmingham

Alabama

Location available
View Birmingham location page
RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
ACTIVE_NOT_RECRUITING

New Haven

Connecticut

Location available
View New Haven location page
NOT_YET_RECRUITING

Durham

North Carolina

Location available
View Durham location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

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Find More Lung Cancer Trials by City

Browse all lung cancer clinical trials in these cities β€” not just this study.

Looking for Non-Small Cell Lung Cancer Treatment in Birmingham?

Join others in Alabama exploring innovative treatment options through clinical research

Non-Small Cell Lung Cancer Treatment Options in Birmingham, Alabama

If you're searching for Non-Small Cell Lung Cancer treatment in Birmingham, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Birmingham, Los Angeles, New Haven and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Non-Small Cell Lung Cancer. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 107 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Non-Small Cell Lung Cancer?

Potential Benefits

  • βœ“Access to new treatment approaches before public availability
  • βœ“Close monitoring by experienced medical professionals
  • βœ“Study-related care provided at no cost
  • βœ“Contribute to medical research for Non-Small Cell Lung Cancer

What to Expect

  • β†’Initial screening to determine eligibility
  • β†’Regular check-ups and monitoring visits
  • β†’Possible compensation for time and travel
  • β†’You can withdraw at any time

Frequently Asked Questions About This Non-Small Cell Lung Cancer Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07098988. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.