Can an Immune-Boosting antibody extend life in advanced lung cancer?
NCT ID NCT03789604
First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time
Summary
This trial is investigating whether adding an experimental antibody called CS1001 to standard chemotherapy can help people with stage IV non-small cell lung cancer. The study compares the combination against chemotherapy alone in patients who have not yet received treatment for advanced disease. The goal is to see if the antibody slows cancer progression and improves survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CS1001, an experimental monoclonal antibody, combined with standard platinum-based chemotherapy
- What this could lead to
- If effective, this combination could become a new first-line treatment option for stage IV non-small cell lung cancer, potentially extending the time before the cancer worsens and improving overall survival.
- What could go wrong
- This is an early-phase test in a specific patient group, and the added antibody may not improve outcomes or could increase side effects. Results are not yet available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
479 people
The number who actually took part.
- Started
-
Dec 2018
- Finished
-
Jul 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Willing to participate in this trial; fully understand and informed of this trial, and able to provide written informed consent form (ICF). 2. 18-75 years of age (18 and 75 included) on the day of signing ICF. 3. 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. 4. Subjects haven't received systemic treatment for advanced/metastatic NSCLC. 5. Measurable target lesion evaluated by investigators according to RECIST v1.1. 6. ECOG PS of 0-1. 7. Life expectancy ≥ 12 weeks. 8. 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. 9. Subjects must have adequate organ function. 10. 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: 1. Histologically confirmed small cell lung cancer or containing small cell component. 2. Subjects with current active autoimmune disease or prior history of autoimmune disease. 3. Malignancies other than NSCLC within 5 years prior to randomization. 4. Known history of human immunodefiency virus (HIV) infection and/or acquired immune deficiency syndrome. 5. Subject with active hepatitis B or hepatitis C. 6. Subjects with known history of alcoholism or drugs abuse. 7. Has a known hypersensitivity to any component of study treatment, for example pemetrexed, cisplatin, carboplatin or other platinum compounds. 8. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
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Other studies related to the condition(s) this trial covers.
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