Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer

Innovent Biologics

Status and phase: Active, not recruiting; Phase 3

Conditions: Non-Small Cell Lung Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05116462

CIBI308G301

Details and patient eligibility

About

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).

Enrollment: 506 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects must sign the written informed consent form (ICF), and be able to follow the visits and relevant procedures specified in the protocol.
2. Age ≥ 18 years.
3. Cytologically or histologically confirmed primary NSCLC (including adenocarcinoma, squamous cell carcinoma).
4. 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).
5. Deemed radically resectable with curative intent.
6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
7. Have not received any prior systemic anti-tumor therapy or local radiotherapy for NSCLC.

Exclusion criteria

1. Subjects with confirmed or suspected brain metastases.
2. Currently participating in an interventional clinical study or treatment with another study drug or study device within 4 weeks prior to randomization.
3. 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
4. Received a live attenuated vaccine 4 weeks prior to randomization (or planned to receive a live attenuated vaccine during the study).
5. Requiring long term systemic corticosteroids
6. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive), known active syphilis.
7. Active hepatitis B.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

506 participants in 2 patient groups, including a placebo group

Sintilimab

Experimental group

Description:

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.

Treatment:

Drug: Sintilimab

Drug: Pemetrexed

Drug: Nab paclitaxel

Drug: Cisplatin

Drug: Carboplatin

Drug: Paclitaxel

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Pemetrexed

Drug: Nab paclitaxel

Drug: Cisplatin

Drug: Carboplatin

Drug: Placebo

Drug: Paclitaxel