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NCT Number: NCT03789604

A Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer

This is a multi-center, randomized, double-blind, phase III study to evaluate the efficacy and safety of CS1001 in combination with platinum-containing chemotherapy versus placebo in combination with chemotherapy in first-line treatment-naive subjects with stage IV non-small cell lung cancer (NSCLC).

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing to participate in this trial; fully understand and informed of this trial, and able to provide written informed consent form (ICF).
  • 18-75 years of age (18 and 75 included) on the day of signing ICF.
  • Histologically or cytologically confirmed stage IV non-small cell lung cancer (staged according to the 8th International Association for the Study of Lung Cancer (IASLC) classification.
  • Subjects haven't received systemic treatment for advanced/metastatic NSCLC.
  • Measurable target lesion evaluated by investigators according to RECIST v1.1.
  • ECOG PS of 0-1.
  • Life expectancy ≥ 12 weeks.
  • Subject with prior anti-cancer treatment can only be enrolled when all toxicities except for hearing loss, alopecia and fatigue, of prior anti-cancer treatment has recovered to ≤ Grade 1 according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
  • Subjects must have adequate organ function.
  • Women of childbearing potential (WOBPC, as defined in section 13.5) must have a negative pregnancy test ≤7 days prior to the first dose of investigational product. WOBCP or fertile men and their WOBCP partners must agree to use an effective method of birth control from providing signed ICF and for 6 months after last dose of investigational product.

Exclusion criteria

  • Histologically confirmed small cell lung cancer or containing small cell component.
  • Subjects with current active autoimmune disease or prior history of autoimmune disease.
  • Malignancies other than NSCLC within 5 years prior to randomization.
  • Known history of human immunodefiency virus (HIV) infection and/or acquired immune deficiency syndrome.
  • Subject with active hepatitis B or hepatitis C.
  • Subjects with known history of alcoholism or drugs abuse.
  • Has a known hypersensitivity to any component of study treatment, for example pemetrexed, cisplatin, carboplatin or other platinum compounds.
  • Subjects with other conditions that in the investigator's opinion may influence subject's compliance or make subjects not suitable for participating in this trial.

Treatment and study plan

CS1001 monoclonal antibody

Biological

Participant will receive CS1001 monoclonal antibody 1200 mg by intravenous infusion every 3 weeks, for up to 24 months; Drug Carboplatin on Day 1 of each 21-day cycle; Drug Pemetrexed on Day 1 of each 21-day cycle; Drug Paclitaxel on Day 1 of each 21-day cycle

CS1001 placebo

Biological

Participant will receive CS1001 placebo 1200 mg by intravenous infusion every 3 weeks, for up to 24 months; Drug Carboplatin on Day 1 of each 21-day cycle; Drug Pemetrexed on Day 1 of each 21-day cycle; Drug Paclitaxel on Day 1 of each 21-day cycle

Primary outcomes

  1. Progression-free survival (PFS) in all subjects evaluated by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Time frame: up to approximately 5 years

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: up to approximately 7 years

    OS defined as the time from randomization to all-cause death.

  2. PFS assessed by BICR

    Time frame: up to approximately 5 years

    PFS defined as the time from randomization to the first occurrence of disease progression or all-cause death (whichever occurs first), as determined by the BICR according to RECIST v1.1

  3. PFS in subgroup of participants with PD-L1 Expression≥1%, as determined by the investigator

    Time frame: up to approximately 5 years

    PFS after randomization as determined by the investigator according to RECIST v1.1 in the subgroup of patients with PD-L1 expression ≥1% defined by the SP263 immunohistochemistry (IHC) assay.

  4. Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1

    Time frame: up to approximately 5 years

    ORR, defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions >=4 weeks apart, as determined by the investigator according to RECIST v1.1.

  5. Duration of response (DOR) assessed by the investigator according to RECIST v1.1

    Time frame: up to approximately 5 years

    DOR defined as the time between the date of the earliest qualifying response and the date of progressive disease or all-cause death, whichever occurs first, as determined by the investigator according to RECIST v1.1.

  6. Safety and tolerability of CS1001 or placebo in combination with platinum-based chemotherapy

    Time frame: up to approximately 5 years

  7. Pharmacokinetics (PK) and immunogenecity of CS1001

    Time frame: up to approximately 5 years

  8. Efficacy of CS1001 monotherapy in subjects cross over to receive CS1001 who experienced progressive disease after assigned to the placebo group in the double-blind phase (CS1001 or placebo in combination with chemotherapy)

    Time frame: up to approximately 5 years

Sponsors and collaborators

Lead sponsor

CStone Pharmaceuticals

Industry

Registry information

Official study title

A Multi-Center, Randomized, Double-Blind, Phase III Study of Platinum-Containing Chemotherapy With or Without CS1001 in Stage IV Non-Small Cell Lung Cancer Subjects

Important dates

Study start
2018
Primary completion
2023
Study completion
2026
First posted
Dec 28, 2018
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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