Low-dose Radiotherapy Combined With Concurrent Chemotherapy, Toripalimab and Tifcemalimab in the Treatment of ES-SCLC

NCT06732258 | Withdrawn Phase 1

• 1 other identifier: CONTEST
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the tolerability and safety of Low-dose radiotherapy combined with concurrent Chemotherapy, Toripalimab and Tifcemalimab in first-line treatment of Extensive-Stage Small Cell Lung Cancer, and to determine the RP2D.

Conditions

Extensive-stage Small-cell Lung Cancer

Keywords

ES-SCLC; Toripalimab; Tifcemalimab; LDRT

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Dose-limiting Toxicitys (DLTs)

  up to 21 days after the first dose

Secondary Outcomes (5)

• Objective response rate (ORR)

  up to 2 years

• Disease control rate (DCR)

  up to 2 years

• Duration of response (DOR)

  up to 2 years

• Progression-free survival (PFS)

  up to 2 years

• Overall Survival (OS)

  up to 2 years

Study Arms (1)

Low-dose radiotherapy concurrent Chemotherapy combined with Toripalimab and Tifcemalimab

EXPERIMENTAL

Radiation: Low-dose radiotherapy; Drug: Tifcemalimab injection; Drug: Toripalimab; Drug: Cisplatin; Drug: Carboplatin; Drug: Etoposide

Interventions

Low-dose radiotherapy RADIATION

The LDRT deals with primary tumour in a 15 Gy of 5 fractions over five days, starting from Day 1 in the first cycle.

Low-dose radiotherapy concurrent Chemotherapy combined with Toripalimab and Tifcemalimab

Tifcemalimab injection DRUG

100 mg or 200 mg q3w until disease progression or intolerable toxicity;

Low-dose radiotherapy concurrent Chemotherapy combined with Toripalimab and Tifcemalimab

Toripalimab DRUG

240 mg q3w until disease progression or intolerable toxicity;

Low-dose radiotherapy concurrent Chemotherapy combined with Toripalimab and Tifcemalimab

Cisplatin DRUG

75 mg/m2 q3w for 4-6 cycles;

Low-dose radiotherapy concurrent Chemotherapy combined with Toripalimab and Tifcemalimab

Carboplatin DRUG

AUC = 5, q3w for 4-6 cycles;

Low-dose radiotherapy concurrent Chemotherapy combined with Toripalimab and Tifcemalimab

Etoposide DRUG

100 mg/m2, d1, d2, d3, q3w for 4-6 cycles;

Low-dose radiotherapy concurrent Chemotherapy combined with Toripalimab and Tifcemalimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years, male or female;
• Histologically or cytologically confirmed extensive stage small cell lung cancer;
• Previously untreated extensive stage small cell lung cancer;
• ECOG PS 0-1;
• Measurable lesions according to RECIST 1.1, and measurable lesions can only be included in previously irradiated lesions if the lesion shows definite disease progression after radiotherapy;
• Expected survival ≥ 3 months;
• Normal function of major organs, that is, meet the following criteria: neutrophils ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 90 g/L; serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min; serum total bilirubin ≤ 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; ALT and AST ≤ 5 × ULN in patients with liver metastases; international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN unless the subject is receiving anticoagulant therapy, activated partial thrombin time (aPTT) ≤ 1.5 × ULN unless the subject is receiving anticoagulant therapy;
• Female subjects of childbearing potential, as well as male subjects with partners of childbearing potential, need to use a medically recognized contraceptive (such as an intrauterine device, contraceptive, or condom containing spermicide) during study treatment and for at least 4 months after the last use of study drug;
• Voluntary participation in this study, signed informed consent, good compliance, with follow-up.

You may not qualify if:

• Mixed SCLC and non-small cell lung cancer (NSCLC);
• Symptomatic, untreated or progressive central nervous system (CNS) metastases;
• Received any systemic anti-tumor therapy for ES-SCLC;
• Previously received any immune checkpoint inhibitors, including but not limited to CTLA-4 inhibitors, PD-1/PD-L1 inhibitors, BTLA inhibitors;
• Known hypersensitivity to the study drug or excipients, known serious allergic reactions to any monoclonal antibody;
• Pulmonary artery invasion;
• History of leptomeningeal disease;
• Uncontrollable tumor-related pain;
• Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
• Uncontrolled or symptomatic hypercalcemia;
• Uncontrolled hypertension, history of hypertensive crisis or hypertensive encephalopathy;
• Patients with active autoimmune diseases, autoimmune diseases or systemic use of steroids/immunosuppressive agents;
• History of idiopathic pulmonary fibrosis, tissue pneumonia, drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on chest CT scan;
• Active pulmonary tuberculosis, or patients with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or patients with a history of active pulmonary tuberculosis infection more than 1 year ago but without regular treatment;
• Known human immunodeficiency virus (HIV) infection, active hepatitis B or C patients; HBsAg positive patients may participate in this study if HBV DNA testing is \< 500 IU/ml or if the lower limit of detection at the site. HCV antibody positive patients may participate in this study if HCV RNA detection is less than the lower limit of detection value at the site where they are located;

Sponsors & Collaborators

• Sichuan University: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Radiotherapy; toripalimab; Cisplatin; Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 13, 2024
• Study Start: January 10, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): February 29, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share