RightFit
RecruitingPhase 2

Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced 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 whether using risk level and protein test results to guide treatment can help people live for 12 months without their lung cancer getting worse. It is for adults with advanced non-small cell lung cancer who have not had drug treatment for their advanced cancer.

This is a phase 2, pragmatic, 1:1 randomized, open-label study that evaluates risk-adapted, proteomic-guided systemic therapy to improve 12-month progression free survival (PFS) among patients with previously untreated advanced non-small cell lung cancer.

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

Eligibility

Who can join

  • You are 18 or older.
  • A tissue test shows non-small cell lung cancer that has spread or cannot be removed by surgery (stage IIIC or IV).
  • Your doctor thinks treatment that helps your immune system fight cancer is right for you, with the goal of easing symptoms rather than curing the cancer.
  • You meet the study’s daily activity score: ECOG 0–2 or Karnofsky 50% or higher.
  • You can understand and are willing to sign the study consent form.
  • You are able and willing to follow all study requirements.

Who can't join

  • Your tumor has a known treatment-sensitive change in ALK, EGFR, HER2, MET exon 14, NTRK, RET, or ROS1. These are genes linked to cancer.
  • Your doctor says another health problem makes immune-based cancer treatment unsafe for you.
  • You have already had drug treatment for stage IIIC or IV non-small cell lung cancer. Prior drug treatment for early-stage or locally advanced cancer is allowed if it ended at least 80 days before you register.
  • The study doctor thinks a condition could affect your safety or ability to follow study rules.

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

Official eligibility criteria

Inclusion Criteria: * Participants must have histologically confirmed non-small cell lung cancer that is metastatic or unresectable (stage IIIC or IV), deemed appropriate to receive standard of care immune checkpoint inhibitor-based therapy given with palliative intent. * Age ≥18 years at the time of consent. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥50%). * Ability to understand and willingness to sign the informed consent form (ICF). * Stated ability and willingness to adhere to all protocol requirements while on study Exclusion Criteria: * Tumor with known sensitizing alteration in ALK, EGFR, HER2, MET exon 14, NTRK, RET, or ROS1. * Medical comorbidities precluding immune checkpoint inhibitor-based therapy per treating investgator's discretion. * Previous systemic therapy for metastatic Stage IIIC or IV NSCLC. Patients who previously completed systemic therapy for early stage or locally advanced NSCLC ≥ 80 days prior to trial registration are eligible for inclusion. * Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on study

Study sites (4)

CA