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RecruitingPhase 2

Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC

Ph 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab and Nivolumab With or Without Docetaxel Versus Docetaxel in 2L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-02)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests visugromab and nivolumab, with or without the chemotherapy drug docetaxel, compared with docetaxel alone. It is for people with stage IV non-squamous non-small cell lung cancer (NSCLC), a type of lung cancer that has spread. Their cancer must have gotten worse after one treatment that included a checkpoint inhibitor, a drug that helps the immune system fight cancer.

This is an exploratory, signal-finding, randomized, placebo-controlled, blinded, multi-center phase 2b trial of the anti-GDF-15 antibody Visugromab (CTL-002) at two different dose levels plus Nivolumab with Docetaxel versus Visugromab at the higher dose plus Nivolumab with placebo versus double-placebo with Docetaxel, in participants that receive second-line treatment for non-squamous NSCLC after failure of prior first-line treatment including a CPI (checkpoint inhibitor). The trial consists of 3 Parts: an open-label Safety Run-in part (Part A) followed by a subsequent randomized phase 2b part with 4 treatment arms. After the treatment of 15 participants with visugromab at the expansion dose, an interim safety and preliminary efficacy analysis will be conducted (Part B), followed by the treatment of the remaining participants (Part C).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage IV non-squamous NSCLC confirmed by a tissue or cell test.
  • Have no cancer gene changes, such as EGFR or ALK changes, that call for an available targeted drug.
  • Have had one prior treatment plan for lung cancer that has spread. It must have included an approved PD-1 or PD-L1 checkpoint inhibitor.
  • Have received the checkpoint inhibitor for at least 12 weeks without the cancer getting worse during that time.
  • The cancer must then have grown or returned while still taking the checkpoint inhibitor. Stopping for side effects or other reasons does not qualify.
  • Have cancer that the study doctor can measure using standard rules.
  • Be expected by the study doctor to live at least 3 months.
  • Be fully active or able to do light work despite limits on hard physical activity.

Who can't join

  • Have had more than one prior treatment plan using drugs that act throughout the body for advanced or spread NSCLC.
  • Have a previous cancer that needs treatment.
  • Have active cancer in the brain, spinal cord, or their lining, such as cancer spread causing symptoms.
  • Have an active autoimmune disease, where the immune system attacks the body, that needed whole-body treatment in the past 3 months.
  • Have interstitial lung disease, which affects tissue around the lung's air sacs; current lung inflammation called pneumonitis; or past pneumonitis not caused by infection that needed whole-body steroid treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Main Inclusion Criteria: * Participants must have histologically or cytologically confirmed diagnosis of stage IV non-squamous NSCLC. * Participants must have demonstrated absence of actionable mutations (e.g. EGFR, ALK, among others) that suggest/require treatment with available targeted agent. * Participants must have failed one line of prior systemic treatment for metastatic NSCLC containing an approved anti PD (L)1 checkpoint inhibitor (CPI). The minimum treatment duration on this regimen must have been 12 weeks exposure for the CPI with no documented progression in this period. Failure of the prior line of systemic treatment for metastatic NSCLC must have occurred under ongoing CPI treatment. Discontinuation of the prior CPI and line of treatment due to AEs, or any other reason than progression/relapse does not permit enrollment. * Participants must have measurable disease determined by the local site Investigator by their assessment per RECIST v1.1. * Participants must have life expectancy of at least 3 months as assessed by the Investigator. * Participants must have ECOG performance status ≤1. Main Exclusion Criteria: * Participants must not have received more than one line of prior systemic treatment for advanced/metastatic NSCLC. * Participants must not have a prior malignancy requiring treatment. * Participants must not have a known or detected clinically active central nervous system (CNS) involvement by NSCLC or other tumors, e.g., with symptomatic metastases and/or carcinomatous meningitis * Participants must not have any active autoimmune disease that has required systemic treatment in past 3 months before planned treatment start (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). * Participants must not have interstitial lung disease or a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis.

Study sites (5)

AL

CA

NC

NY