Radiation plus drug cocktail shows promise for resistant lung cancer
NCT ID NCT06775743
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding precise radiation (SBRT) to a four-drug combination (sintilimab, bevacizumab, and chemotherapy) can help people with advanced EGFR-mutant lung cancer whose tumors have stopped responding to standard targeted therapy. About 53 participants will receive the drug combo first, then personalized radiation to any remaining tumors. Researchers will measure how long the cancer stays under control and any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sintilimab, bevacizumab, platinum-doublet chemotherapy, and stereotactic body radiotherapy
- What this could lead to
- If it works, this could offer a new treatment option for people with a specific type of advanced lung cancer that has stopped responding to standard pills.
- What could go wrong
- This is a small, early-phase study (53 people) with no control group, so results may not apply broadly. The combination therapy can cause significant 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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 53 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2025
- Expected to finish
-
Jun 2027
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 years and older
- Sex
-
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: * ECOG performance status score of 0-1; * Histologically or cytologically confirmed stage IV primary non-small cell lung cancer; * EGFR-sensitive mutations (L858R, 19del); * Resistance to first-line treatment with third-generation EGFR-TKIs; * At least one measurable lesion; * Patients with brain metastases may be included, but they must be asymptomatic neurologically and have stable lesions without the need for systemic corticosteroid treatment; * Men and women of reproductive age agree to contraception during the trial (surgical sterilization or oral contraceptives/intrauterine device + condoms); * Life expectancy ≥ 3 months; * Within one week before enrollment, organ function levels must meet the following criteria: 1. Bone marrow function: Hemoglobin ≥ 80 g/L, white blood cell count ≥ 4.0 × 10\^9/L or neutrophil count ≥ 1.5 × 10\^9/L, platelet count ≥ 100 × 10\^9/L; 2. Liver: Serum total bilirubin level ≤ 1.5 times the upper limit of normal, and when serum total bilirubin level \> 1.5 times the upper limit of normal, direct bilirubin level must be ≤ the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal; 3. Kidney: Serum creatinine level \< 1.5 times the upper limit of normal or creatinine clearance rate ≥ 50 ml/min, blood urea nitrogen ≤ 200 mg/L; serum albumin ≥ 30 g/L; * Patients must have the capacity to understand and voluntarily sign the informed consent form. Exclusion Criteria: * Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc. * Symptomatic interstitial lung disease or active infectious/non-infectious pneumonia. * Patients with risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for intestinal perforation. * History of other malignant tumors. * Patients with active infections, heart failure, myocardial infarction within the past 6 months, unstable angina, or unstable arrhythmias. * Physical examination or clinical laboratory findings that the investigator believes may interfere with the results or increase the risk of treatment complications, or other uncontrollable diseases. * Patients whom the investigator believes currently have lesions requiring palliative radiation therapy. * Mixed with small cell lung cancer components. * Nursing or pregnant women. * Congenital or acquired immunodeficiency diseases including human immunodeficiency virus (HIV), or history of organ transplantation or allogeneic stem cell transplantation. * Known hepatitis B virus (HBV), hepatitis C virus (HCV), or active tuberculosis infection. * Patients who have received cancer vaccines or received other vaccines within 4 weeks before starting treatment (Note: Seasonal influenza vaccines are often inactivated vaccines and are allowed, while intranasal preparations are usually live attenuated vaccines and are not allowed). * Patients who are concurrently using other immunotherapies, chemotherapy drugs, drugs from other clinical trials, or require long-term corticosteroid treatment are not eligible for enrollment. * Patients with psychiatric disorders, substance abuse, or social issues that affect compliance are not eligible for enrollment after physician review. * Patients who are allergic to or contraindicated for PD-1 monoclonal antibodies, VEGF monoclonal antibodies, or chemotherapy drugs. Withdrawl criteria: * Incorrectly enrolled participants. Those who have not yet received treatment in this study should be immediately withdrawn, and their information will not be included in the study analysis. If treatment has already begun, the investigator should assess the participant's benefit-risk profile and then decide whether to withdraw. If withdrawal is necessary, the participant should exit the study after completing treatment and follow-up and will not be included in the efficacy analysis of this study, but must be included in the safety analysis. * Participants who experience the following during the pre-treatment evaluation phase: new systemic diseases or worsening of existing systemic diseases that meet exclusion criteria; voluntary withdrawal, loss to follow-up, or death; poor compliance. * Participants whom the investigator deems necessary to exclude. The investigator must report the reason for exclusion to the principal investigator and obtain consent. Those who have not yet received treatment in this study should be immediately withdrawn, and their information will not be included in the study analysis. If treatment has already begun, the participant should exit the study after completing treatment and follow-up and will not be included in the efficacy analysis of this study, but must be included in the safety analysis. * Participants may request to withdraw from the clinical trial at any time during the trial process. * Participants who experience serious adverse events during the trial, and whom the investigator deems should stop participating in the trial. * Participants whose condition worsens during the trial, potentially threatening their life, or who develop other conditions that affect trial observations. * Participants who are lost to follow-up or die during the treatment phase. * Participants who use chemotherapy, traditional Chinese medicine, other immunotherapy drugs, radiotherapy sensitizers, or other agents that affect efficacy and toxicity evaluation during the trial period. * Participants in whom serious deviations occur during the implementation of the clinical trial protocol, making it difficult to evaluate the drug's effect; those with poor compliance. Exit criteria: * Wrong enrollees who did not meet the inclusion criteria; * Serious protocol violations.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for EGFR mutation positive advanced non-small cell lung cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can zapping residual lung cancer spots extend remission?
- New drug takes aim at ROS1-Positive lung cancer in Head-to-Head trial
- Can a targeted drug plus brain radiation shrink lung cancer brain tumors?
- Can a Two-Drug combo outsmart tough lung cancer?
- Can a new Antibody-Drug conjugate outsmart advanced lung cancer?
- Experimental pill SHY-ONC6 takes on Hard-to-Treat cancers