Study of Low-Dose Radiotherapy (LDRT) Concurrent Cisplatin/Carboplatin Plus Etoposide With Atezolizumab for Patients With Extensive-Stage Small Cell Lung Cancer

NCT04622228 | Completed Phase 2

• 1 other identifier: ML42391
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 8

Brief Summary

This is a Phase II, single arm, multicenter study designed to evaluate the safety and efficacy of low-dose radiotherapy (LDRT) concurrent cisplatin/carboplatin plus etoposide with atezolizumab in participants who have extensive-stage small cell lung cancer (ES-SCLC) and are chemotherapy-navïe for their extensive-stage disease.

Conditions

Carcinoma, Small Cell Lung

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Objective response rate (ORR), defined as the proportion of participants with a complete response (CR) or partial response (PR) on two consecutive occasions \>= 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).

  Baseline up to approximately 36 months

Secondary Outcomes (7)

• Duration of Response

  Baseline to disease progression or death from any cause (whichever occurs first)(up to approximately 36 months)

• Disease Control Rate (DCR)

  Baseline up to approximately 36 months

• Progression Free Survival (PFS)

  Baseline to the first occurrence of disease progression or death from any cause (whichever occurs first) (up to approximately 36 months)

• PFS Rate at 6 Months and 1 Year

  Baseline up to 1 year

• Overall Survival (OS)

  Baseline until death (up to approximately 36 months)

Study Arms (1)

LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab

EXPERIMENTAL

Participants will receive the following treatment regimens: LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab. Induction treatment will be administered on a 21-day cycle for four cycles. Concurrent radiation therapy will be conducted from Day 1 - Day 5 in the first cycle. Following the induction phase, participants will continue maintenance therapy with atezolizumab. Participants will be treated until loss of clinical benefit, or unaccepted toxicity, or withdrawal of consent, or death (whichever occurs first).

Drug: Atezolizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Etoposide; Radiation: Thoracic radiation therapy (TRT)

Interventions

Atezolizumab DRUG

Atezolizumab will be administered by intravenous infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status.

Also known as: Tecentriq

LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab

Cisplatin DRUG

Cisplatin will be administered as intravenous infusion at a dose of 75 mg per meter squared (75 mg/m\^2) after completion of atezolizumab on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).

LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab

Carboplatin DRUG

Carboplatin will be administered as intravenous infusion at a dose of area under the concentration-time curve (AUC) of 5 mg/mL/min on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).

LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab

Etoposide DRUG

Etoposide will be administered intravenously at a dose of 100 mg/m\^2 on Days 1, 2 and 3 of each 21-day cycle during the induction phase (Cycles 1-4).

LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab

Thoracic radiation therapy (TRT) RADIATION

Participants will receive concurrent thoracic radiation therapy (TRT) treatment, in once daily fractions, 3 Gy per fraction, to a target dose of 15 Gy in 5 fractions from Day 1-Day 5 in the first cycle.

LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed ES-SCLC
• No prior treatment for ES-SCLC
• Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation.
• ECOG performance status of 0 or 1
• Life expectancy \>= 3 months
• Adequate hematologic and end-organ function
• For participants receiving therapeutic anticoagulation: stable anticoagulant regimen
• Negative human immunodeficiency virus (HIV) test at screening
• Negative hepatitis B surface antigen (HBsAg) test at screening
• Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb), or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test. The HBV DNA test must be performed for participants who have a negative HBsAg test, a negative HBsAb test, and a positive total HBcAb test.
• Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test must be performed for participants who have a positive HCV antibody test.
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

You may not qualify if:

• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
• History of leptomeningeal disease
• Uncontrolled tumor-related pain
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
• Uncontrolled or symptomatic hypercalcemia
• Active or history of autoimmune disease or immune deficiency
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
• Active tuberculosis
• Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
• History of malignancy other than small cell lung cancer (SCLC) within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (8)

Cancer Hospital , Chinese Academy of Medical

Beijing, 100021, China

Location

Hunan Cancer Hospital

Changsha, 410013, China

Location

West China Hospital - Sichuan University

Chengdu, 610047, China

Location

Second Affiliated Hospital of Third Military Medical University

Chongqing, 400030, China

Location

Shanghai Pulmonary Hospital

Shanghai, 200433, China

Location

Fudan University Shanghai Cancer Center; Medical Oncology

Shanghai, 201315, China

Location

Tianjin Cancer Hospital

Tianjin, 300060, China

Location

Central South Hospital, Wuhan University

Wuhan, 430000, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

atezolizumab; 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)

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 Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 9, 2020
• Study Start: December 16, 2020
• Primary Completion: June 21, 2022
• Study Completion: June 30, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (8)