RightFit
RecruitingPhase 2

A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)

An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)

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 new treatment combinations for adults with non-small cell lung cancer (NSCLC) that has spread nearby or to other parts of the body. It checks how safe the treatments are, how well people tolerate them, and whether they help fight the cancer. Different study groups test different combinations.

This is a Phase II, multi-center, open-label platform study evaluating novel combination treatment options in participants with locally advanced or metastatic NSCLC. The study will consist of several sub-studies, each evaluating the safety, tolerability, and preliminary antitumour activity of various treatment combinations. This study will be conducted in approximately 80 centers globally across 10 countries.

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

Eligibility

Who can join

  • Be at least 18 years old when signing the consent form.
  • Be fully active or able to do light work, with limits on hard physical activity.
  • Have at least one tumor that can be measured under the study’s rules.
  • Have bone marrow and organs that work well enough.
  • Be expected to live at least 12 weeks.
  • Provide a tumor tissue sample that meets the study’s needs.
  • Groups 1 and 2: Have advanced or spreading NSCLC confirmed by tissue or cell tests. PD-L1, a protein on tumor cells, must be at least 50% for group 1 or 1–49% for group 2. Certain EGFR or ALK gene changes and other known gene changes that can guide treatment must be absent.
  • Group 3: Have advanced or spreading non-squamous NSCLC, a specific lung cancer type, confirmed by tissue or cell tests. Have a gene change that can guide treatment, and cancer that worsened after treatment aimed at that change.

Who can't join

  • A severe or poorly controlled illness that the study doctor thinks makes joining unsafe or following study rules difficult; poorly controlled or serious heart disease.
  • Current or past inflammatory disease or autoimmune disease, where the immune system attacks the body.
  • Lasting moderate or worse side effects from earlier cancer treatment, except hair loss; or a history of another cancer.
  • Brain cancer spread that is not stable. Groups 1 and 2 also exclude pressure on the spinal cord or cancer in the lining around the brain and spinal cord. Group 3 excludes unstable pressure on the spinal cord.
  • An active infection, including tuberculosis (TB), HIV, hepatitis B, or hepatitis C.
  • Past treatment that acts through the immune system, or any current cancer treatment. Groups 1 and 2 also exclude past chemotherapy, chemotherapy with radiation, or immunotherapy for advanced NSCLC.
  • A history of poorly controlled high blood pressure, active bleeding disease, high bleeding risk, or blood-clotting disorders.
  • A live, weakened vaccine within 30 days before the first study treatment.

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

Official eligibility criteria

Inclusion Criteria for All Sub-studies: * Participant must be ≥ 18 years of age at the time of signing the ICF * WHO/ECOG performance status of 0 or 1 * At least 1 lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline. * Adequate bone marrow and organ function * Life expectancy ≥ 12 weeks * Provision of acceptable tumour tissue Specific Inclusion Criteria for Sub-Study 1 and Sub-Study 2: * Histologically or cytologically documented advanced or metastatic NSCLC * PD-L1 TC ≥ 1% (TC≥ 50% for sub-study 1, 1-49% for sub-study 2) * Absence of sensitizing EGFR mutations or ALK rearrangements. No known other Actionable Genomic Alterations(AGAs) Specific Inclusion Criteria for Sub-Study 3: * Histologically or cytologically documented advanced or metastatic non-squamous NSCLC * Documented positive AGA and had progressed on prior targeted therapy Exclusion Criteria for All Sub-studies: * As judged by the investigator, any severe or uncontrolled systemic diseases, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol * Active or prior documented autoimmune or inflammatory disorders * Persistent toxicities (CTCAE Grade ≥ 2) (NCI CTCAE v5.0) caused by previous anti cancer therapy, excluding alopecia. * Spinal cord compression or leptomeningeal carcinomatosis for sub-study 1 and sub-study 2. Unstable spinal cord compression for sub-study 3 * Unstable brain metastases * History of another primary malignancy. * Active infection, including TB and infections with HIV, HBV (verified by known positive HBsAg result), HCV. * Uncontrolled or significant cardiac disease * Receipt of prior systemic chemotherapy/chemoradiation/immunotherapy for advanced NSCLC for sub-study 1 and sub-study 2. * Prior exposure to immune-mediated therapy * History of uncontrolled hypertension, and active bleeding diseases, and high risks of bleeding and disorders of coagulation * Any concurrent anti-cancer treatment. * Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention.

Study sites (6)

CA

GA

MD

TX

VA