RightFit
RecruitingPhase 2

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

Phase 2 Study to Evaluate Reduced Dose Chemotherapy in Combination With Anti-PD-1 Therapy as First Line Treatment in Vulnerable or Older Adults (Vulnerable or Age ≥70) With Advanced PD-L1 TPS <50% Non-small Cell Lung Cancer

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 lower-dose chemotherapy with immunotherapy, a treatment that helps the immune system fight cancer. It looks at how often side effects cause vulnerable older adults to stop chemotherapy. It is for people with advanced or returned non-small cell lung cancer whose tumors have a PD-L1 score below 50%.

Evaluate frequency of adverse events that lead to chemotherapy discontinuation in vulnerable older adults with recurrent/metastatic PD-L1 TPS\<50% NSCLC patients who receive reduced dose chemotherapy in combination with immunotherapy.

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

Eligibility

Who can join

  • Have non-small cell lung cancer confirmed by a tissue or cell test.
  • Have stage IIIB, IIIC, or IV cancer, or cancer that has returned and cannot be treated with the goal of a cure.
  • Have had no treatment for cancer that has returned or spread. Treatment before or after surgery is allowed if it ended more than 6 months before joining.
  • Be age 70 or older, or meet the study’s definition of frailty.
  • Have a PD-L1 score below 50% and no cancer gene changes with an FDA-approved targeted drug for first treatment. Gene testing is optional for squamous cell cancer.
  • Have cancer that can be measured on scans and an ECOG activity score of 0–3, which rates your ability to do daily tasks.
  • Meet the study’s blood cell count and liver test limits. Blood transfusions are allowed.
  • Be able to understand the study and willing to sign a consent form.

Who can't join

  • Be expected to live less than 3 months when joining.
  • Have an active autoimmune disease, where the immune system attacks the body, that needed whole-body treatment in the past 2 years.
  • Have interstitial lung disease, which causes lung inflammation or scarring.
  • Have a kidney filtering rate below 30 mL/min.
  • Have untreated cancer in the brain or spinal cord that causes symptoms, or cancer in the tissue and fluid around them. Brain or spinal cord cancer that is treated or causes no symptoms is allowed.
  • Need ongoing medicines that weaken the immune system. Exceptions include steroids equal to no more than 10 mg of prednisone daily, short steroid courses stopped before joining, inhaled or nose-spray steroids, skin steroids, and decreasing doses of dexamethasone for swelling linked to brain or spinal cord disease.

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

Official eligibility criteria

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) (either squamous or non- squamous) * Stage IIIB, IIIC or IV disease OR have recurrent disease and not be candidates for curative treatment such as combined chemo-radiation * No previous line of treatment in the recurrent or metastatic setting. Neoadjuvant or adjuvant treatment more than 6 months before enrollment is acceptable. * Age 70 or meeting frailty definition or above at the date of signing informed consent * Absence of driver mutations that have first line Food and Drug Administration (FDA) approved targeted therapy (biomarker testing is optional for squamous cell) * PD-L1 tumor proportion score (TPS) of less than 50% * Eastern Cooperative Oncology Group (ECOG) PS of 0-3 * Have measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment * Absolute neutrophil count (ANC) ≥ 1,000/μL * Platelets ≥ 75,000/μL * Hemoglobin (Hgb) ≥ 8.0 g/dL (transfusion permitted) * Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) * Aspartate amino transferase (AST)serum glutamic-oxaloacetic transaminase (SGOT) /alanine aminotransferase (ALT)serum glutamic-pyruvic transaminase (SGPT) ≤ 5.0 × institutional ULN * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Participants with life expectancy of less than 3 months at the time of enrollment * Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, or immunosuppressive drugs) * Diagnosis of interstitial lung disease * Creatinine clearance of \<30 mL/min * Symptomatic, untreated central nervous system (CNS) disease or leptomeningeal disease. Patients with asymptomatic or treated CNS disease are eligible * Required ongoing use of immunosuppressive medication, including steroids, with the following allowable exceptions: * Doses less than or equal to the equivalent of prednisone 10 mg daily * Short courses of steroids that are discontinued prior to enrollment * Inhaled, intranasal and/or topical steroids * Dexamethasone taper for treating vasogenic edema associated with CNS disease

Study sites (2)

VA