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Can an immunotherapy drug revive the fight against resistant lung cancer?
NCT ID NCT03924050
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial is testing whether adding the immunotherapy drug toripalimab to standard chemotherapy can help people with advanced non-small cell lung cancer whose tumors have a specific EGFR mutation and have stopped responding to TKI targeted therapy. About 440 participants will be randomly assigned to receive either toripalimab plus chemotherapy or a placebo plus chemotherapy. The study aims to see if the combination improves overall survival and other outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- toripalimab (an immunotherapy drug) combined with standard chemotherapy
- What this could lead to
- If it works, this combination could offer a new treatment option for people with EGFR-mutated lung cancer whose tumors have stopped responding to TKI therapy, potentially extending survival.
- What could go wrong
- This is a phase III trial, but results are not yet known. The drug may not improve outcomes for all participants, and immunotherapy can cause immune-related side effects.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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440 people
The number who actually took part.
- Started
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May 2019
- Finished
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Feb 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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: Only the patients meeting all the following criteria can be eligible to participate in the trial: * Fully informed consent and signed ICF; * Age of 18-75 years; * Histologically and/or cytologically confirmed advanced or recurrent stage III B-C or IV (AJCC Version 8) NSCLC with TKI-resistant EGFR-mutated tumors, which also satisfy following conditions: Without T790M mutation in exon 20 after 1st or 2nd generation EGFR-TKI (eg, gefitinib, erlotinib, icotinib, afatinib,etc.) treatment failure;If with T790M mutation in exon 20 after 1st or 2nd generation EGFR-TKI (eg, gefitinib, erlotinib, icotinib, afatinib,etc.),participants are required to have osimertinib or other 3rd generation EGFR-TKI treatment failure prior to enrollment.Participants with osimertinib treatment failure as 1st line therapy (regardless of their EGFR T790M mutation status);Previous neoadjuvant/adjuvant chemotherapy is allowed, but the time interval between the last dose of chemotherapy and recurrence/metastasis must be at least 6 months. * With at least one measurable disease per RECIST 1.1; * Agree to provide formalin fixed tumor specimen after EGFR-TKI treatment failure or provide fresh biopsy tissue; * ECOG performance status of 0-1; * Life expectancy ≥ 3 months; * Good organ function; * Any adverse event resulting from prior treatment, surgery, or radiotherapy must return to grade 0 or 1 according to NCI-CTCAE v5.0, except for alopecia of any grade; * Willing and able to follow protocol visits, treatment plans, laboratory tests and other study procedures; * Women of childbearing potential must have negative serum pregnancy test within 3 days prior to the first dose of investigational product: Exclusion Criteria: * Exclusion of tumor histology or cytology confirmed the presence of small cell lung cancer components, or squamous cell carcinoma components of more than 10%; * Combined with other driver mutations with known therapeutic drug, including but not limited to: ALK rearrangement, ROS1 mutation, BRAF600E mutation; * Previous systematic chemotherapy for advanced NSCLC; * Subjects with no measurable lesions; * Subjects with cancer meningitis and spinal cord compression; * Subjects with untreated central nervous system (CNS) tumor metastasis; * Subjects were previously treated with an anti-PD-1, anti-PD-L1 or anti-CTLA-4 agent; * Subjects with any active, known or suspected autoimmune disease; * Subjects who are now participating in other clinical studies or the last dose of prior investigational drug was given in \< 4 weeks (or 5 half-lives) from the first investigational product administration of this study; * Subjects who were expected to receive any other antitumor therapy (eg, other maintenance therapy for NSCLC, radiotherapy, and/or surgical excision); * Subjects who received major surgery within 4 weeks prior to enrollment or were not fully recovered from prior surgery; * Subjects with other malignancies requiring concurrent treatment; * Subjects with grade II or above myocardial ischemia or myocardial infarction, or subjects with arrhythmia with poor control; * Subjects with uncontrolled pleural/pericardial effusion, or with ascites requiring repeated drainage; * Subjects with uncontrolled tumor-related pain; * Subjects with severe allergic reactions to other monoclonal antibodies and subjects with severe allergic reactions to pemetrexed, platinum or its prophylaxis; * Subjects with psychological disorder, alcohol alcoholism, drug abuse or drug dependency
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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
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Peking University Shenzhen Hospital
Shenzhen, China
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Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
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Other studies related to the condition(s) this trial covers.
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