Adebrelimab Combined with Chemotherapy and Thoracic Radiotherapy for First-line Treatment of ES-SCLC

NCT06672133 | Not Yet Recruiting Phase 3

• 1 other identifier: MA-SCLC-III-023
• Study Type: interventional
• Target: 524
• Locations: 0 countries
• Sites: N/A

Brief Summary

This phase III trial compares the effect of adding radiation therapy to the usual maintenance therapy with adebrelimab versus adebrelimab alone in patients who have already received debrelimab plus chemotherapy for the treatment of extensive stage small cell lung cancer.

Conditions

Extensive Stage Lung Small Cell Carcinoma

Keywords

adebrelimab; radiotherapy; ES-SCLC

Outcome Measures

Primary Outcomes (2)

• PFS

  Up to approximately 36 months

• OS

  Up to approximately 36 months

Secondary Outcomes (6)

• ORR

  Up to approximately 36 months

• DoR

  Up to approximately 36 months

• DCR

  Up to approximately 36 months

• 6m and 1-year PFS rate

  6 Months and 12 Months

• 1- and 2-year OS rates

  1 year and 2 years

Other Outcomes (1)

• To detect biomarkers associated with efficacy

  Up to approximately 36 months

Study Arms (2)

Arm Combined Radiotherapy

EXPERIMENTAL

After randomization，patients receive adebrelimab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy QD on days 1-5 during weeks 1-5 only. Patients undergo CT, MRI or PET/CT scan,throughout the trial. Patients also undergo blood and tissue collection throughout the trial.

Drug: Adebrelimab; Radiation: Radiation Therapy

Arm Non-radiotherapy

ACTIVE COMPARATOR

After randomization，patients receive adebrelimab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI or PET/CT scan,throughout the trial. Patients also undergo blood and tissue collection throughout the trial.

Drug: Adebrelimab

Interventions

Adebrelimab DRUG

Given：IV

Also known as: SHR-1316

Arm Combined Radiotherapy; Arm Non-radiotherapy

Radiation Therapy RADIATION

Undergo radiation therapy

Also known as: RT, Radiotherapy, Consolidation radiotherapy, Irradiation

Arm Combined Radiotherapy

Eligibility Criteria

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

You may qualify if:

• Aged 18-75 years, male or female;
• Histologically or cytologically confirmed extensive stage small cell lung cancer (according to the Veterans Lung Administration Lung Study Group, VALG stage);
• ECOG performance status score 0 \~ 1;
• No prior line of systemic therapy for ES-SCLC;
• Liver metastases ≤ 3 at diagnosis;
• Patients without previous brain metastases or treated asymptomatic CNS metastases,
• Expected survival ≥ 12 weeks;
• At least one measurable target lesion (according to RECISTv1.1 criteria) on imaging assessment (CT or MRI) within 4 weeks prior to enrollment;
• The function of vital organs meets the requirements;
• Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and must agree to use effective contraception during the trial and 2 months after the last dose of adalimumab or 6 months after the chemotherapy agent, whichever is longer;
• Patients voluntarily join this study, sign informed consent, have good compliance, and cooperate with follow-up.

You may not qualify if:

• Histologically or cytologically determined as a mixed pathological type with components such as non-small cell lung cancer;
• Active or untreated CNS metastases detected by computed tomography (CT) or magnetic resonance imaging (MRI) during the screening period and previous imaging assessments;
• Spinal cord compression that is not relieved by surgery and/or radiotherapy;
• Clinically symptomatic third space effusion requiring repeated drainage within 2 weeks, such as pericardial effusion, pleural effusion, and abdominal effusion that are still uncontrollable by pumping or other treatments;
• Complicated with other malignant tumors ≤ 5 years before the first dose, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical resection (hormone therapy for non-metastatic prostate cancer or breast cancer is allowed);
• Patients with active, known, or suspected autoimmune disease. Patients with type 1 diabetes treated with stable doses of insulin, hypothyroidism requiring hormone replacement therapy only, and skin diseases (e.g., eczema, vitiligo, or psoriasis) not requiring systemic therapy and not exacerbated within the year before the screening period were excluded;
• Patients diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy not directly related to tumor therapy within 7 days before the first dose of study drug; physiological doses of glucocorticoids (prednisone ≤ 10 mg/day or equivalent) are allowed;
• HBsAg positive and HBV DNA copy number greater than the upper limit of normal (1000 copies/ml or 500 IU/ml), or HCV positive (HCV RNA or HCV Ab detection suggests acute and chronic infection); known HIV positive history or known acquired immunodeficiency syndrome (AIDS);
• A history of idiopathic pulmonary fibrosis, interstitial pneumonia, tissue pneumonia (such as occlusive vasculitis), drug-induced pneumonia, radiation pneumonitis requiring steroid therapy or clinically symptomatic active pneumonia; or other severe lung disease that seriously affects lung function;
• Patients with active pulmonary tuberculosis (TB) or history of active pulmonary tuberculosis infection ≤ 48 weeks before screening, regardless of treatment;
• Presence of severe infection at randomization, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc.;
• Major surgery within 28 days prior to randomization, or planned major surgery during the study period;
• Use of live attenuated vaccines within 28 days prior to randomization, or anticipated need for live attenuated vaccines during the study;
• Cardiac function and disease which is considered clinically significant by the investigator;
• Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation;

Sponsors & Collaborators

• Jinming Yu: lead

MeSH Terms

Interventions

Radiotherapy; Radiation

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena

Central Study Contacts

Llinlin Wang, PhD

CONTACT

+86-15665785800; wanglinlinatjn@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President of Shandong Cancer Hospital，Academician of Chinese Academy of Engineering

Model Details: Subjects who had SD/PR/CR assessed after induction immunotherapy were randomized 1:1 with PFS and OS set as co-primary endpoints for this study. The HR of mOS in the maintenance phase was conservatively estimated to be meaningful in the adalimumab combined with thoracic radiotherapy group compared with the adalimumab group, with a significance level α of 0.05 (2-sided), and no less than 80% OS events would be observed (1-β difference between the 375 groups). A total of 471 subjects are required to be enrolled. Considering a dropout rate of 10%, 524 subjects were required. In summary, a total of at least 524 subjects were required to be enrolled in this study.

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: November 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share