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Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer (NSCLC)

Status

Not yet recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Sintilimab

Carboplatin

Nab-paclitaxel

Cisplatin

Pemetrexed

Docetaxel

Paclitaxel

Gemcitabine

Placebo

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 IIB (primary tumor > 4 cm), 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.
-

Exclusion Criteria:

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. -

Sites / Locations

Shanghai Pulmonary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sintilimab

Placebo

Arm Description

Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus platinum-based chemotherapy prior to surgery. adjuvant Treatment period: Subjects will 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 1 year.

Neoadjuvant Treatment period: up to 3 cycles of placebo plus platinum-based chemotherapy prior to surgery. adjuvant Treatment period: Subjects will 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 1 year.

Outcomes

Primary Outcome Measures

Event Free Survival (EFS)

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

Pathological Complete Response (pCR) Rate

pCR rate is defined as absence of residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy

Secondary Outcome Measures

Disease free survival (DFS)

DFS is defined as the time from surgery to disease recurrence or death due to any cause.

Major Pathological Response (mPR) Rate

mPR rate is defined as ≤ 10% residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy.

Overall survival (OS)

OS is defined as the time from randomization to death due to any cause.

Safety parameters: AEs

The relationship of study drug and the severity of all adverse events (AEs)

Safety parameters:IRRs

The relationship of study drug and the severity of infusion-related reactions (IRRs).

Safety parameters: surgery delay rate

The relationship of study drug and the severity of surgery delay rate.

Immunogenicity-ADA

The positive rate of anti-drug antibody (ADA)

Immunogenicity-NAb

The positive rate of neutralizing antibody (NAb)

Full Information

NCT ID

NCT05116462

First Posted

October 26, 2021

Last Updated

November 2, 2021

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05116462

Brief Title

Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer

Official Title

A Multi-Regional, Randomized, Double-blind, Phase 3 Study of the Efficacy and Safety of Sintilimab Plus Chemotherapy vs Placebo Plus Chemotherapy Before Surgery and Sintilimab vs Placebo After Surgery for Resectable Non-small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 11, 2021 (Anticipated)

Primary Completion Date

August 18, 2023 (Anticipated)

Study Completion Date

June 20, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is a multi-regional, randomized, double-blind Phase 3 study to compare the efficacy and safety of sintilimab plus chemotherapy (sintilimab combination) vs placebo plus chemotherapy (placebo combination) before surgery and sintilimab vs placebo after surgery in treatment-naive subjects with resectable Stage IIB (primary tumor > 4 cm) to IIIB (resectable N2 only) non-small cell lung cancer (NSCLC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer (NSCLC)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sintilimab

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Sintilimab

Intervention Description

200 mg D1 IV Q3W

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Nab-paclitaxel

Intervention Description

100 mg/m2 D1, 8, 15 IV Q3W

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

75 mg/m2 D1 IV Q3W

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Intervention Description

500 mg/m2 D1 IV Q3W

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

60 or 75 mg/m2 D1 IV Q3W

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

175 or 200 mg/m2 D1 IV Q3W

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

1000 mg/m2 or 1250 mg/m2 D1, 8 IV Q3W

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

20 ml D1 IV Q3W

Primary Outcome Measure Information:

Title

Event Free Survival (EFS)

Description

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

Time Frame

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

Title

Pathological Complete Response (pCR) Rate

Description

pCR rate is defined as absence of residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy

Time Frame

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

Secondary Outcome Measure Information:

Title

Disease free survival (DFS)

Description

DFS is defined as the time from surgery to disease recurrence or death due to any cause.

Time Frame

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

Title

Major Pathological Response (mPR) Rate

Description

mPR rate is defined as ≤ 10% residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy.

Time Frame

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

Title

Overall survival (OS)

Description

OS is defined as the time from randomization to death due to any cause.

Time Frame

Up to approximately 5.4 years

Title

Safety parameters: AEs

Description

The relationship of study drug and the severity of all adverse events (AEs)

Time Frame

Up to approximately 5.4 years

Title

Safety parameters:IRRs

Description

The relationship of study drug and the severity of infusion-related reactions (IRRs).

Time Frame

Up to approximately 5.4 years

Title

Safety parameters: surgery delay rate

Description

The relationship of study drug and the severity of surgery delay rate.

Time Frame

Up to approximately 5.4 years

Title

Immunogenicity-ADA

Description

The positive rate of anti-drug antibody (ADA)

Time Frame

Up to approximately 1.6 years

Title

Immunogenicity-NAb

Description

The positive rate of neutralizing antibody (NAb)

Time Frame

Up to approximately 1.6 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 IIB (primary tumor > 4 cm), 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. - Exclusion Criteria: 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. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rong Xing

Phone

+86 010 87705665

Rong.Xing@innoventbio.com

Facility Information:

Facility Name

Shanghai Pulmonary Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200433

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Caicun Zhou

Phone

021-65115006-3049

caicunzhoudr@163.com

12. IPD Sharing Statement

Learn more about this trial

Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer

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