Advanced Lung Carcinoma Clinical Trial
Official title:
A Study of LK101 Combined With PD-1 or PD-L1 Monoclonal Antibody in the Treatment of Lung Cancer to Evaluate the Safety, Tolerability and Preliminary Efficacy
This is a open lable, single-center phase Ib/IIa study for patients with local advanced or metastastic NSCLC or ES-SCLC, who failed with previous anti-PD-1/PD-L1 therapy. The aim is to observe and evaluate the safety, tolerability and efficacy of LK101 injection combined with pembrolizumab or durvalumab respectively in the incurable NSCLC and SCLC.
This study is designed to evaluate the safety and efficacy of LK101 injection combined with pembrolizumab or durvalumab, which devided into 2 cohorts: cohort 1: patients with locally advanced or metastastic (stage IIIB-IV) NSCLC who has progressed/relapsed after anti-PD-1/PD-L1 therapy. eligible subjects will receive LK101 injection and pembrolizumab treatment. cohort 2: patients with extensive SCLC who failed with at least first-line standard therapy with PD-L1. eligible subjects will receive LK101 injection and durvalumab treatment. LK101 will be administered in a prime-boost schedule of 4 priming vaccination followed by 3 booster vaccinations. For the priming phase: LK101 administered once a week at Days 1, 8, 15, 22. For the booster phase: total of 3 vaccinations will be given, Q3W from the end of priming dose. Treatment can be continued according to the investigator's evaluation, subsequent treatment is administered Q6W. Patients will receive a combination of pembrolizumab(200mg IV) Q3W and durvalumab (1500mg IV) Q3W in NSCLC and SCLC,respectively, until disease progression (PD), intolerable toxicity. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03776253 -
Conquer Fear SUPPORT Intervention in Supporting Patients With Stage III-IV Lung or Gynecologic Cancer
|
N/A | |
| Not yet recruiting |
NCT06374160 -
Exercise in Patients With Advanced Non-small Cell Lung Cancer
|
N/A | |
| Active, not recruiting |
NCT04819997 -
A Nurse-Led Intervention for Fear of Progression in Advanced Cancer
|
N/A | |
| Recruiting |
NCT05256290 -
Phase 1/2 Study of BDTX-1535 in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05274451 -
A Study to Investigate LYL797 in Adults With Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT04785287 -
Anti-CTLA4-NF mAb (BMS986218), Nivolumab, and Stereotactic Body Radiation Therapy for the Treatment of Metastatic Solid Malignancies
|
Phase 1/Phase 2 | |
| Completed |
NCT05342571 -
A Biobehavioral/Cognitive Treatment for Stress, Depression, and Anxiety in Patients With Stage IV Lung Cancer
|
N/A | |
| Completed |
NCT04229381 -
Resiliency Among Older Adults Receiving Lung Cancer Treatment
|
N/A | |
| Active, not recruiting |
NCT05640765 -
BeWell360-CG Care Model: Health and Wellness Coaching to Support Caregivers of Patients Living With Advanced Lung Cancers
|
N/A | |
| Not yet recruiting |
NCT04702009 -
Efficacy and Safety of First-line Anti-PD-1/PD-L1 Monoclonal Antibody in Combination With Chemotherapy and Bronchoscopy-assisted Interventional Therapy in Patients With Advanced Central Non-small Cell Lung Cancer
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT03707938 -
Local Consolidative Therapy and Brigatinib in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer
|
Phase 1 | |
| Recruiting |
NCT05969860 -
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
|
Phase 2 | |
| Recruiting |
NCT04924192 -
A Clinical Study of TQB3616 Capsules Combined With Anlotinib Hydrochloride Capsules or Standard Chemotherapy Second-line and Above in the Treatment of Advanced Lung Cancer
|
Phase 2 | |
| Recruiting |
NCT06343402 -
Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
|
Phase 1 |