Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Randomized, Double-blind, Phase 3 Study of the Efficacy and Safety of Sindilizumab Combined With Chemotherapy or Placebo Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer (ORIENT-99)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05116462
• Other study ID #: CIBI308G301
• Status: Recruiting
• Phase: Phase 3
• Start date: March 15, 2024
• Est. completion date: October 14, 2028

Study information

• Verified date: March 2024
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: chunxian Hu
• Phone: +86 021 3183 7200
• Email: chunxian.hu[@]innoventbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 14, 2028
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Pemetrexed
500 mg/m2 D1 IV Q3W
• Carboplatin
AUC 5 or 6 mg/ml/min D1 IV Q3W
• Paclitaxel
175 or 200 mg/m2 D1 IV Q3W
• Sintilimab
200 mg D1 IV Q3W
• Cisplatin
75 mg/m2 D1 IV Q3W
• Nab paclitaxel
100 mg/m2 D1, 8, 15 IV Q3W
• Placebo
20 ml D1 IV Q3W

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 )
Primary	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	Disease free survival (DFS)	DFS is defined as the time from surgery to disease recurrence or death due to any cause.	Up to approximately 2 years following the begining of Post-operative Assessment baseline(up to Study 5.4 years )
Secondary	Major Pathological Response (mPR) Rat	mPR rate is defined as = 10% residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy.	Up to approximately 6 weeks following completion of neoadjuvant treatment (up to Study 2 years)
Secondary	Overall survival (OS)	OS is defined as the time from randomization to death due to any cause.	Up to approximately 5.4 years
Secondary	Safety parameters:AE	The relationship of study drug and the severity of all adverse events (AEs), treatment emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), immune-related adverse events (irAEs), serious adverse events (SAEs), infusion-related reactions (IRRs) and surgery delay rate.	Up to approximately 5.4 years