RecruitingPhase 2

Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy

Phase II Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-Small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy

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 small study tests whether the same first treatment with chemotherapy and immune-based therapy works as well and is as safe for people with lung cancer who are less active as for those who are more active. It is for adults with non-small cell lung cancer that has spread or cannot be removed by surgery and has no standard treatment that can cure it.

This pilot study is configured as a non-inferiority comparison of Performance Status 2 patients with Performance Status 0-1 patients, with the goal of demonstrating non-inferiority in terms of efficacy (progression-free survival, overall survival) and safety (rates of adverse events, quality of life) when treating Performance Status 2 patients with the same first-line immunotherapy-based regimen as Performance Status 0-1 patients.

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

Eligibility

Who can join

  • Age 18 or older.
  • Tests of cells or tissue show non-small cell lung cancer that has spread or cannot be removed by surgery, with no standard cure.
  • No past chemotherapy or immune-based therapy given without the goal of a cure. Past treatment meant to cure early-stage cancer is allowed.
  • A doctor rates your daily activity level as ECOG 0–2: from fully active to able to care for yourself but unable to work.
  • Expected to live more than 3 months.
  • Adequate organ and bone marrow function, with infection-fighting cells at least 1,000/mcL and platelets, which help blood clot, at least 100,000/mcL.
  • Men and women who could become pregnant must agree to use birth control before joining and during the study. Report any possible pregnancy to the doctor right away.
  • Able to understand the study and willing to sign a consent form.

Who can't join

  • A known tumor gene change in EGFR, ALK, ROS1, or B-Raf for which gene-targeted drugs should be the first treatment. Missing gene test results do not always prevent joining.
  • An active autoimmune disease, where the immune system attacks the body, that needed medicines acting throughout the body in the past 2 years.
  • Past lung swelling not caused by infection that needed steroid medicines acting throughout the body.
  • An uncontrolled illness, such as an active infection or serious heart problem, or mental health or social issues that would prevent following study rules.
  • Pregnancy. Breastfeeding must stop during treatment.

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

Official eligibility criteria

Inclusion Criteria: * Patients must have a cytological or histological diagnosis of non-small cell lung cancer that is metastatic or unresectable for which standard curative measures do not exist. * No prior systemic treatment with either chemotherapy or immunotherapy for non-curative intent. Patients may have previously received cancer treatment with curative intent for prior early-stage disease. * At least 18 years old. * ECOG performance status of 0-2, as determined by the treating physician in the consult note. * Life expectancy of greater than 3 months. * Patients must have normal organ and marrow function as defined below: absolute neutrophil count ≥1,000/mcL platelets ≥100,000/mcL * Chemotherapy agents are known to be teratogenic, therefore women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Ability to understand and the willingness to sign an IRB-approved informed consent document. Exclusion Criteria: * Nonsmall cell lung cancer that is known at registration to be positive for a tumor activating alteration for which first line targeted therapy is indicated; specifically, a targetable mutation in epidermal growth factor receptor (EGFR), gene rearrangement of anaplastic lymphoma kinase (ALK), gene rearrangement of c-ros oncogene 1 (ROS1), or mutation in B isoform of rapidly accelerated fibrosarcoma (B-Raf). For non-squamous subtypes, molecular testing of tumor and peripheral blood should be attempted for actionable biomarkers, but if there is an insufficient quantity of tumor material for testing and it is not feasible to attempt additional biopsies before starting systemic therapy, then these biomarker results are not necessary for inclusion on the study. For squamous subtype, molecular testing should be considered but is not necessary for inclusion on the study. * Known to have an active autoimmune disease that required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, systemic corticosteroids, or immunosuppressive drugs). * History of (non-infectious) pneumonitis that required systemic corticosteroids. * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects with chemotherapy. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy, breastfeeding should be discontinued.

Study sites (2)

NC