Low-dose Radiotherapy Combined With Durvalumab, Chemotherapy(EP) in the Treatment of ES-SCLC

NCT05092412 | Unknown Phase 2

• 1 other identifier: ESR-20-20849
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study was to evaluate the efficacy of low-dose radiotherapy (LDRT) combined with durvalumab, etoposide, and cisplatin/carboplatin in the first-line treatment of extensive-stage small cell lung cancer.

Conditions

Lung Cancer; Extensive-stage Small-cell Lung Cancer; Durvalumab

Keywords

ES-SCLC; Durva; LDRT

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  The time from the date of first dosing of durvalumab to the first appearance of objective disease progression (according to RECIST1.1) or death from any cause (if it occurs before disease progression).

  up to 2 years

Secondary Outcomes (3)

• median overall survival（mOS）

  up to 2 years

• Objective response rate (ORR)

  up to 2 years

• 6-month progression-free survival rate / 12-month progression-free survival rate (PFS6/12)

  1 years

Study Arms (1)

Low-dose radiotherapy combined with durvalumab, etoposide, and cisplatin/carboplatin

EXPERIMENTAL

Radiation: Low-dose radiotherapy; Drug: Durvalumab; Drug: Etoposide, and cisplatin/carboplatin

Interventions

Low-dose radiotherapy RADIATION

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

Low-dose radiotherapy combined with durvalumab, etoposide, and cisplatin/carboplatin

Durvalumab DRUG

Durvalumab 1500 mg intravenous infusion, started to be used simultaneously with chemotherapy at week 0 and continued after chemotherapy.

Low-dose radiotherapy combined with durvalumab, etoposide, and cisplatin/carboplatin

Etoposide, and cisplatin/carboplatin DRUG

Starting from week 0, the dose of etoposide + carboplatin or cisplatin in the study will not exceed the dose for specific indications in the product instructions (etoposide \[80 to 100mg/m2\] via intravenous infusion and carboplatin \[ The area under the curve (AUC) is 5-6\] by intravenous infusion or cisplatin \[75-80 mg/m2\] by intravenous infusion), using up to 4 cycles. The choice of platinum drugs is at the discretion of the investigator.

Low-dose radiotherapy combined with durvalumab, etoposide, and cisplatin/carboplatin

Eligibility Criteria

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

You may qualify if:

• At the time of screening, male or female participants were ≥18 years old.
• Before carrying out any research program related procedures (including screening evaluation), obtain written informed consent and any locally required authorization from the participant or his legal representative.
• Extensive-stage disease confirmed by histology or cytology (American Joint Committee on Cancer (8th edition) stage IV SCLC \[any T, any N and M1a/b/c\]), or due to multiple lung nodules with a wide range Or the size of the tumor/nodule is too large to be included in a tolerable radiotherapy plan for stage T3-4 disease.
• Participants with brain metastases must be asymptomatic or stable with steroids and anticonvulsants for at least 1 month before study treatment. Participants with suspected brain metastases during screening should undergo brain CT/MRI before enrollment in the study.
• The participant must be considered suitable for platinum-based chemotherapy as the first-line treatment for extensive-stage small cell lung cancer. Chemotherapy must include either cisplatin or carboplatin, combined with etoposide.
• The participant must be considered suitable for thoracic radiotherapy as the first-line treatment for extensive-stage small cell lung cancer.
• Life expectancy on the first day of study treatment was ≥12 weeks.
• At the time of enrollment, the World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) physical status score was 0 or 1.
• Weight\>30 kg.
• According to the requirements of RECIST1.1 guidelines, at least one lesion (never received radiotherapy before), accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) at baseline shows that its longest diameter is ≥10mm (except for lymph nodes, Its short axis must be ≥15 mm); and the lesion is suitable for repeated and accurate measurement.
• Have not been exposed to immune-mediated therapies in the past, including but not limited to other anti-PD-1, anti-PD-L1 and anti-programmed cell death ligand 2 (anti-PD-L2) antibodies, except for therapeutic anti-tumor vaccines.
• With sufficient organ and bone marrow function, it needs to be measured 28 days before receiving treatment, which is defined as follows:
• Hemoglobin ≥9 g/dL. Absolute neutrophil count ≥ 1.5 × 109/L (granulocyte colony stimulating factor is not allowed during screening).
• Platelet count ≥75 × 109/L. Serum bilirubin ≤1.5 × upper limit of normal (ULN). It is not applicable to participants diagnosed with Gilbert syndrome. These participants are allowed to enter into the group through consultation with the investigators.
• For participants without liver metastasis: ALT and AST ≤2.5 × ULN. The ALT and AST of participants with liver metastases are ≤5 × ULN.

You may not qualify if:

• Participate in the design and execution of the study (applicable to researchers and/or members of the research center).
• Have previously received the distribution of experimental drug (IP) in this study.
• Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or the follow-up phase of an interventional study.
• Etoposide-platinum (carboplatin or cisplatin)-based chemotherapy is medically contraindicated.
• Have a history of chest radiotherapy or plan to undergo intensive chest radiotherapy before systemic treatment. Radiotherapy outside the chest (eg, bone metastases) for the purpose of palliative care is allowed, but it must be completed before the first administration of the study drug.
• Simultaneously carry out any chemotherapy, biological products or hormone therapy for cancer treatment. The use of hormone therapy for non-cancer related conditions (eg, hormone replacement therapy) is acceptable.
• Major surgery (defined by the investigator) within 28 days before the first IP administration. Note: Local surgery on isolated lesions for the purpose of palliative care is acceptable.
• History of allogeneic organ transplantation.
• Paraneoplastic syndromes (PNS) with autoimmune properties requiring systemic treatment (systemic steroids or immunosuppressive agents) or clinical symptoms suggesting that PNS is aggravated.
• Active or previously recorded autoimmune diseases or inflammatory diseases (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], diverticulitis \[except diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome \[granulomatous vasculitis, Graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]). For this standard, the following exceptions:
• Participants with vitiligo or hair loss. Participants with hypothyroidism (eg after Hashimoto syndrome) and stable disease after receiving hormone replacement therapy.
• Any chronic skin disease that does not require systemic treatment. Participants without active disease in the past 5 years can be included in the study after discussion with the investigators.
• Participants with celiac disease who can be controlled by diet alone.
• Uncontrolled concurrent diseases, including but not limited to: persistent or active infections, interstitial lung disease, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmia, concomitant Severe chronic gastrointestinal disease with diarrhea, or psychiatric/social problem conditions that may limit compliance with research requirements, cause a significant increase in the risk of AEs, or affect the participant's ability to provide written informed consent.
• A history of another type of primary malignant tumor, except for the following conditions:

Sponsors & Collaborators

• You Lu: lead
• AstraZeneca: collaborator

Study Sites (3)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

West China Hospital Sichuan University

Chengdu, Sichuan, 610044, China

Location

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MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma

Interventions

Radiotherapy; durvalumab; Etoposide; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; 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; Coordination Complexes

Study Officials

• You Lu, MD

  West China Hospital

  STUDY CHAIR

• Yan Zhang, MD

  West China Hospital

  PRINCIPAL INVESTIGATOR

• Yue Xie, MM

  Chongqing University Cancer Hospital

  STUDY DIRECTOR

• Shu Jie Li, MM

  Chongqing University Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Shun Dong Cang, MD

  Henan Provincial People's Hospital

  STUDY DIRECTOR

• Lu Lu Su, MD

  Henan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 25, 2021
• Study Start: March 2, 2022
• Primary Completion: February 6, 2023
• Study Completion: June 30, 2025
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)