NCT03789604CompletedPhase 3
A Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer
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
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 479 (actual)
- First submitted
- 26 Dec 2018
- Start date
- Dec 2018
- Primary completion date
- May 2023
- Lead sponsor
- CStone Pharmaceuticals
- Diseases
- Lung cancer
- NCT number
- NCT03789604
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 479
- From Dec 2018 to the primary completion date, May 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with current active autoimmune disease or prior history of autoimmune disease.
- Malignancies other than NSCLC within 5 years prior to randomization.
Other illness
- Histologically confirmed small cell lung cancer or containing small cell component.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Pulmonary Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.