BridgeMD
Prevention study for Lung Cancer
Official title Clinical Study on the Prevention of Driver Gene Negative Ib-IIIb Lung Cancer Recurrence and Metastasis by Staged Chinese Herbal Medicine Combined With Chemotherapy and Immune Checkpoint Inhibitors
ClinicalTrials.gov ID: NCT05834413
What this study is testing
What is chemotherapy plus TCM 1&ICIs plusTCM2?
chemotherapy plus TCM 1&ICIs plusTCM2 is an investigational medicine, being studied as a potential treatment for lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This project adopts a prospective, multicenter, randomized controlled clinical study to investigate the treatment of TCM in postoperative patients with driver gene negative lung cancer, according to two phases of postoperative adjuvant therapy: (i) chemotherapy phase immunotherapy phase. In this study, 367 patients (183 in the control group and 184 in the trial group) will be observed over 4 years, and the quality of life, toxic effects and safety of this therapy will be investigated.
- Time commitment: about 4 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74
You may be able to join if
- Patients who underwent complete surgical resection (R0) with postoperative pathology confirmed as stage Ib to IIIb non-small cell lung cancer.
- Patients whose tissue or blood specimens tested negative for driver genes.
- Patients who received their first chemotherapy within 8 weeks postoperatively.
- Age ≥ 18 years ≤ 74 years, regardless of gender.
- Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2 points.
You likely can't join if
- Having unresectable or metastatic disease, pathology reports without a clear pathological diagnosis, showing the presence of residual lesions at the...
- Any medical condition with a life expectancy of less than 5 years, except for risk of recurrent lung cancer.
- Current malignant disease or history of malignant disease (except resected NSCLC), combined with serious diseases of the heart, liver, kidney and...
- With a history of psychiatric disorders that are not easily controlled.
- Patients who are pregnant or lactating.
- Patients who are allergic to therapeutic drugs.
See the full eligibility criteria
- Patients who underwent complete surgical resection (R0) with postoperative pathology confirmed as stage Ib to IIIb non-small cell lung cancer.
- Patients whose tissue or blood specimens tested negative for driver genes.
- Patients who received their first chemotherapy within 8 weeks postoperatively.
- Age ≥ 18 years ≤ 74 years, regardless of gender.
- Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2 points.
- absolute neutrophil value \>1.5×109 /L, platelet count \>80×109 /L, hemoglobin \>90mg/dL; no abnormal liver and kidney function test results.
- Understand and agree to participate in this study and sign the informed consent form.
- Having unresectable or metastatic disease, pathology reports without a clear pathological diagnosis, showing the presence of residual lesions at the microscopic surgical margins, and surgical residual lesions.
- Any medical condition with a life expectancy of less than 5 years, except for risk of recurrent lung cancer.
- Current malignant disease or history of malignant disease (except resected NSCLC), combined with serious diseases of the heart, liver, kidney and hematopoietic system, diagnosed and/or requiring treatment within the...
- With a history of psychiatric disorders that are not easily controlled.
- Patients who are pregnant or lactating.
- Patients who are allergic to therapeutic drugs.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.