Rechallenging immune therapy for advanced lung cancer patients who responded well to initial treatment

A Multicenter, Single-Arm Pilot Study of Immune Checkpoint Inhibitors in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer Who Had Long-Term (Two Years or Longer) Response to First-Line Immunotherapy

This study is testing if giving immune therapy again can help people with advanced lung cancer who did well on their first treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: pembrolizumab, nivolumab, atezolizumab, durvalumab, tislelizumab, toripalimab, sintilimab, camrelizumab, chemotherapy, immunotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT06388031 on ClinicalTrials.gov

What this trial studies

This phase II trial explores the use of immune checkpoint inhibitors (ICIs) as a second-line treatment for patients with advanced non-small cell lung cancer (NSCLC) who previously had a long-term response to first-line immunotherapy. The study aims to evaluate the efficacy and safety of ICI rechallenge in these patients, while also identifying potential biomarkers that could predict treatment efficacy and prognosis. Participants will receive up to 17 cycles of ICI monotherapy, with blood samples collected at various intervals to analyze biomarkers. The study will include a total of 27 participants over a two-year period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with stage III-IV NSCLC who have had a long-term response to first-line immunotherapy.

Not a fit: Patients who have not previously responded to immunotherapy or have other treatment options available may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced NSCLC who have previously benefited from immunotherapy.

How similar studies have performed: Other studies have shown promising results with similar approaches in utilizing immune checkpoint inhibitors for NSCLC, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Participants must have a thorough understanding of this study and voluntarily sign an informed consent form (ICF);
2. Age between 18 and 80 years, any gender;
3. Histologically or cytologically confirmed stage III-IV non-small cell lung cancer (NSCLC);
4. Previous treated with first-line immunotherapy (immunotherapeutic agents include currently marketed anti-PD-L1 or anti-PD-1 monoclonal antibodies: pembrolizumab, nivolumab, atezolizumab, durvalumab, tislelizumab, toripalimab, sintilimab, camrelizumab, etc.; investigational drugs not yet marketed need discussion with the study team prior to enrollment; with or without platinum-based doublet chemotherapy) for at least 35 cycles or disease stability confirmed by imaging assessment for at least 2 years, and disease progression;
5. Measurable disease (at least 1 lesion) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
7. Adequate organ function:

   Hematology: Absolute neutrophil count (ANC) ≥1500/μL; Platelets ≥100000/μL; Hemoglobin ≥9.0g/dL; Renal: Serum creatinine ≤1.5×ULN or calculated creatinine clearance (CrCl) ≥60 mL/min (using Cock-Gault formula); Hepatic: Total bilirubin ≤1.5 ×ULN or, for subjects with total bilirubin levels \>1.5×ULN, direct bilirubin within normal limits; AST (SGOT) and ALT (SGPT) ≤2.5×ULN; Coagulation: International normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (APTT) ≤1.5×ULN;
8. Subjects must be willing and able to comply with study visits, treatment plans, laboratory tests, and other study procedures;
9. Female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use highly effective contraception during the study and for 180 days after the last dose of the study drug.

Exclusion Criteria:

1. Received two or more prior systemic therapies;
2. Known sensitive EGFR mutation (EGFR exon19 del or EGFR exon21 L858R) or ALK rearrangement;
3. Symptomatic or progressing CNS metastases, leptomeningeal metastases;
4. History of autoimmune disease, active autoimmune disease, immunodeficiency, or requiring systemic corticosteroid/immunosuppressive therapy; (except: a history of hypothyroidism; well-controlled stable type I diabetes mellitus);
5. Idiopathic pulmonary fibrosis (including interstitial pneumonia), drug-induced pneumonitis, history of (non-infectious) pneumonia/interstitial lung disease requiring steroid therapy;
6. Known active tuberculosis, human immunodeficiency virus (HIV) infection; active hepatitis B (defined as positive HBsAg or positive hepatitis B virus DNA test result above the detection limit) or hepatitis C (defined as known positive HCV antibody result, known quantitative HCV-RNA analysis result above the detection limit) history; other known active infections requiring systemic therapy;
7. Received systemic immunostimulatory therapy within 4 weeks before initiation of study treatment or within 5 half-lives of the drug (whichever is longer);
8. Pregnancy, lactation, planning to become pregnant, or fathering a child during the anticipated duration of the study (from screening visit to 180 days after the last dose of investigational drug);
9. Prior allogeneic tissue/organ transplantation and other conditions unsuitable for immunotherapy.

Where this trial is running

Beijing

• Peking Union Medical College Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Minjiang Chen, MD. — Peking Union Medical College Hospital
• Study coordinator: Minjiang Chen, MD.

Conditions Non-small Cell Lung Cancer