Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer

NCT05116462 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: CIBI308G301
• Study Type: interventional
• Target: 506
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, double-blind Phase 3 study to compare the efficacy and safety of Sindilizumab combined with chemotherapy or placebo combined with chemotherapy for neoadjuvant and adjuvant therapy for Resectable Stage II to IIIB (resectable N2 only) non-small cell lung cancer (NSCLC).

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Event Free Survival (EFS) in stage III NSCLC

  Up to approximately 2 years following the beginning of Post-operative Assessment baseline(up to Study 2 years )

  Up to approximately 2 years following the beginning of Post-operative Assessment baseline(up to Study 2 years )

• Event Free Survival (EFS) in ITT population

  EFS is defined as the time from randomization to the first recorded time to any first documented progression, recurrence or death, which occurs first.

  Up to approximately 3 years following the beginning of Post-operative Assessment baseline(up to Study 3 years )

Secondary Outcomes (4)

• Disease free survival (DFS)

  Up to approximately 2 years following the begining of Post-operative Assessment baseline(up to Study 5.4 years )

• Major Pathological Response (mPR) Rat

  Up to approximately 6 weeks following completion of neoadjuvant treatment (up to Study 2 years)

• Overall survival (OS)

  Up to approximately 5.4 years

• Safety parameters:AE

  Up to approximately 5.4 years

Study Arms (2)

Sintilimab

EXPERIMENTAL

Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus platinum-based chemotherapy prior to surgery. adjuvant Treatment period: Subjects will receive 1 cycle of sintilimab plus platinum-based chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.

Drug: Pemetrexed; Drug: Carboplatin; Drug: Paclitaxel; Drug: Sintilimab; Drug: Cisplatin; Drug: Nab paclitaxel

Placebo

PLACEBO COMPARATOR

Neoadjuvant Treatment period: up to 3 cycles of placebo plus platinum-based chemotherapy prior to surgery. adjuvant Treatment period: Subjects will receive 1 cycle of placebo plus platinum-based chemotherapy, and then receive placebo therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.

Drug: Pemetrexed; Drug: Carboplatin; Drug: Paclitaxel; Drug: Cisplatin; Drug: Nab paclitaxel; Drug: Placebo

Interventions

Pemetrexed DRUG

500 mg/m2 D1 IV Q3W

Placebo; Sintilimab

Carboplatin DRUG

AUC 5 or 6 mg/ml/min D1 IV Q3W

Placebo; Sintilimab

Paclitaxel DRUG

175 or 200 mg/m2 D1 IV Q3W

Placebo; Sintilimab

Sintilimab DRUG

200 mg D1 IV Q3W

Sintilimab

Cisplatin DRUG

75 mg/m2 D1 IV Q3W

Placebo; Sintilimab

Nab paclitaxel DRUG

100 mg/m2 D1, 8, 15 IV Q3W

Placebo; Sintilimab

Placebo DRUG

20 ml D1 IV Q3W

Placebo

Eligibility Criteria

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

You may qualify if:

• Subjects must sign the written informed consent form (ICF), and be able to follow the visits and relevant procedures specified in the protocol.
• Age ≥ 18 years.
• Cytologically or histologically confirmed primary NSCLC (including adenocarcinoma, squamous cell carcinoma).
• Subjects with Stage II, IIIA or IIIB (resectable N2 only) disease based on the 8th edition of the TNM staging classification for lung cancer issued by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification (AJCC8).
• Deemed radically resectable with curative intent.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
• Have not received any prior systemic anti-tumor therapy or local radiotherapy for NSCLC.

You may not qualify if:

• Subjects with confirmed or suspected brain metastases.
• Currently participating in an interventional clinical study or treatment with another study drug or study device within 4 weeks prior to randomization.
• Received Chinese herbal medicine, Chinese traditional medicine with anti-tumor indications, or drugs with immunomodulatory effects (including thymosin, interferon, interleukin) within two weeks prior to randomization
• Received a live attenuated vaccine 4 weeks prior to randomization (or planned to receive a live attenuated vaccine during the study).
• Requiring long term systemic corticosteroids
• Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive), known active syphilis.
• Active hepatitis B.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Carboplatin; Paclitaxel; sintilimab; Cisplatin; Taxes

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)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Economics; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 11, 2021
• Study Start: March 15, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 14, 2028
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

CN (1)