Combining Toripalimab with chemotherapy and radiation for advanced lung cancer

The Efficacy and Safety of Induction Chemotherapy and Toripalimab Followed by Chemoradiotherapy for Large-volume (Bulky) Local Advanced Non-small Cell Lung Cancer

This study is testing if combining the immunotherapy drug Toripalimab with chemotherapy and radiation can help people with advanced lung cancer feel better and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: Toripalimab, chemotherapy
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05888402 on ClinicalTrials.gov

What this trial studies

This Phase II study evaluates the efficacy and safety of Toripalimab, an immunotherapy drug, in combination with chemotherapy and chemoradiotherapy for patients with large-volume, unresectable locally advanced non-small cell lung cancer (NSCLC). Participants will receive two cycles of induction therapy with Toripalimab and chemotherapy, followed by definitive chemoradiotherapy and additional consolidation therapy with Toripalimab. The study aims to determine how well this treatment approach works in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with unresectable Stage II-III NSCLC and a primary tumor size of at least 5 cm or significant lymph node involvement.

Not a fit: Patients with adenocarcinoma harboring EGFR mutations or ALK rearrangements, or those with other active malignancies, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with large-volume local advanced NSCLC.

How similar studies have performed: Other studies have shown promise in using immunotherapy combined with chemotherapy for lung cancer, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Age 18-70 years; ECOG score 0-2.
2. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
3. Unresectable Stage II-III NSCLC (according to AJCC 8th edition) with maximum tumor diameter T ≥ 5 cm in the primary tumor or minimum diameter N ≥ 2 cm in mediastinal metastatic lymph nodes.
4. No other previous anti-tumor history, at least 3 months of expected survival.
5. No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function.

Exclusion Criteria:

1. Pathologic type was adenocarcinoma with EGFR gene mutation or ALK gene rearrangement.
2. Patients with other active malignancies within 5 years or at the same time.
3. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease, diverticulitis \[except diverticular disease\], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener' s syndrome).
4. History of allogeneic organ transplantation.
5. History of active primary immunodeficiency.
6. Patients with uncontrolled concurrent diseases, including but not limited to persistent or active infection (including tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus, etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active interstitial lung disease, severe chronic gastrointestinal disease with diarrhea or mental illness.
7. Women of child-bearing potential who are pregnant or breastfeeding.
8. Allergic to research drug ingredients.
9. Ongoing or prior use of immunosuppressive agents within 14 days prior to first dose
10. The investigator judged other situations not suitable for inclusion in this study.

Where this trial is running

Beijing, Beijing

• Chinese Academy of Medical Science and Peking Union Medical College — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Nan Bi, MD — Chinese Academy of Medical Science and Peking Union Medical College
• Study coordinator: Nan Bi, MD

Conditions Local Advanced Non-small Cell Lung Cancer