Chemoradiotherapy With or Without Sintilimab in Limited-stage SCLC

NCT04189094 | Unknown Phase 2 DMC

• 1 other identifier: IRB-2019-164
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial.

Conditions

Small Cell Lung Cancer Limited Stage

Keywords

radiotherapy; chemotherapy; immunotherapy; PD-1 inhibitor; lung cancer; small cell; limited-stage

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  PFS, defined as the time from the date of randomization to the first date of documented objective progression disease or of death from any cause.

  2 years

Secondary Outcomes (2)

• Overall survival

  5 years

• Overall response rates

  2 years

Study Arms (2)

Sintilimab + CRT arm

EXPERIMENTAL

Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) plus Sintilimab induction therapy for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions). After PCI, Sintilimab maintenance therapy will be administered once every 3 week for 13 cycles.

Drug: Sintilimab; Drug: Etoposide; Drug: Cisplatin; Radiation: radiotherapy

CRT arm

ACTIVE COMPARATOR

Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions).

Drug: Etoposide; Drug: Cisplatin; Radiation: radiotherapy

Interventions

Sintilimab DRUG

Etoposide and cisplatin (carboplatin) plus Sintilimab induction therapy will be administered for 2 cycles and then thoracic radiotherapy (45 Gy/30 fractions) be administered with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions).Sintilimab maintenance therapy will be administered once every 3 week for 13 cycles.

Sintilimab + CRT arm

Etoposide DRUG

Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.

Also known as: VP-16

CRT arm; Sintilimab + CRT arm

Cisplatin DRUG

cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.

Also known as: DDP

CRT arm; Sintilimab + CRT arm

radiotherapy RADIATION

Thoracic radiotherapy (45 Gy/30 fractions) and prophylactic cranial irradiation (25 Gy/10 fractions).

CRT arm; Sintilimab + CRT arm

Eligibility Criteria

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

You may qualify if:

• Histologically/cytologically confirmed diagnosis of SCLC.
• Radiologically (including brain CT/MRI, chest and abdomen contrasted CT and bone scintigraphy. PET/CT is recommended) confirmed limited-stage.
• Patients should be ≥ 18 years old.
• ECOG performance status of 0-1 (Karnofsky performance status ≥ 80).
• With adequate cardiac, pulmonary, bone marrow, hepatic and renal function.
• With weight loss no more than 10% within 6 months before diagnosis.
• Informed consent must be signed.

You may not qualify if:

• Histology confirmed the mixed NSCLC components;
• Other primary malignant tumors appeared within 5 years before the first administration of the study drug, except for locally curable malignant tumors after radical treatment (such as basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervical or breast carcinoma in situ, etc.);
• Any disease or condition contraindicated by radiotherapy or chemotherapy;
• Malignant pleural effusion and pericardial effusion;
• Pregnant and lactating women;
• History of idiopathic pulmonary fibrosis (IPF), including pneumonia and organic pneumonia;
• Received live vaccination within 28 days before the first administration of the study drug;
• days prior to the first administration of the study drug, he participated in any other drug clinical trials or is undergoing other clinical trials.
• Have received any antibody / drug (including PD-1, PDL1, CTLA4, tim3, Lag3, etc.) targeting T-cell co regulatory protein (immunocheckpoint).
• The investigator believes that the subject's complications or other circumstances may affect the compliance with the protocol or may not be suitable for the study.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Affiliated Hospital of Guangdong Medical University: collaborator
• First People's Hospital of Foshan: collaborator

MeSH Terms

Conditions

Lung Neoplasms

Interventions

sintilimab; Etoposide; Cisplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ming Chen, MD. PhD.

  Cancer Hospital of the University of Chinese Academy of Science (Zhejiang Cancer Hospital)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Chen, MD. PhD.

CONTACT

86-571-88122199; chenming@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 6, 2019
• Study Start: January 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2023
• Last Updated: December 6, 2019

Record last verified: 2019-11