Neoadjuvant Chemotherapy Sequentially Combined with Sintilimab in Resectable EGFR-Mutant NSCLC
NCT06688656 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2024-11-14
Summary
This study is a prospective, single-arm, single-center Phase II trial, aiming to investigate efficacy and safety of neoadjuvant chemotherapy sequentially combined with sintilimab in resectable EGFR-mutant stage II-IIIB non-squamous NSCLC patients
Conditions
Interventions
- DRUG
-
Pemetrexed 500 mg/m2
1\. Pemetrexed: 500mg/m² on Day 1, Q3W, administered via intravenous infusion for a total of 3 cycles.
- DRUG
-
AUC=5 on Day 1, Q3W,administered via intravenous infusion for a total of 3 cycles.
- DRUG
-
Sintilimab
Sintilimab, 200mg, administered via intravenous infusion on the 3rd day of each cycle, Q3W, for a total of 3 cycles.
Sponsors & Collaborators
-
Shanghai Chest Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-31
- Primary Completion
- 2026-03-31
- Completion
- 2028-03-31
Countries
- China
Study Locations
More Related Trials
-
Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC
NCT05011487 ·Status: RECRUITING ·Phase: PHASE2
-
Neoadjuvant Immunotherapy in EGFR-mutant Localized NSCLC
NCT05244213 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Sintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure
NCT03802240 ·Status: COMPLETED ·Phase: PHASE3
-
Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer
NCT06755684 ·Status: RECRUITING ·Phase: PHASE2
-
A Multicenter Phase II Randomized Trial of Limertinib Followed by Sintilimab and Chemotherapy vs. Limertinib Followed by Limertinib and Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIB EGFR-Mutant NSCLC
NCT07038460 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Intermittent and Maintenance of Erlotinib in Combination With Pemetrexed/Carboplatin in Ⅲb/IV Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
NCT02066038 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of Pemetrexed and Gefitinib Versus Gefitinib in Non-Small Cell Lung Cancer (NSCLC)
NCT01469000 ·Status: COMPLETED ·Phase: PHASE2
-
Third-generation EGFR-TKI Plus Anlotinib as Maintenance for NSCLC With Small Cell Transformation After EGFR-TKI Resistance
NCT06634667 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Neoadjuvant Toripalimab for Non-squamous NSCLC With EGFR Mutation
NCT05962021 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Study of AK119 and AK112 With or Without Chemotherapy for NSCLC Patients
NCT05636267 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Phase II Study of Atezolizumab in Combination With Bevacizumab, Carboplatin or Cisplatin, and Pemetrexed for EGFR-mutant Metastatic Non-small Cell Lung Cancer Patients After Failure of EGFR Tyrosine Kinase Inhibitors.
NCT04147351 ·Status: COMPLETED ·Phase: PHASE2
-
A Clinical Trial of Furmonertinib Combination Therapy As Neoadjuvant Treatment in Resectable EGFR-Mutated NSCLC
NCT06585644 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Efficacy of Targeted Therapy Combined Chemotherapy in Advanced EGFR Positive NSCLC Patients
NCT04552613 ·Status: COMPLETED ·Phase: NA
-
Genius Study Study to Compare Efficacy and Safety of Gefitinib/ Pemetrexed With Pemetrexed Alone as Maintenance Therapy in Patients With Stage IV EGFR Mutation Negative or T790M Single Mutation Who Respond to Pemetrexed/ Platinum as First-line Therapy
NCT01579630 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Influence of Prior Chemotherapy on Clinical Benefit With Erlotinib in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer With or Without EGFR Gene Mutation
NCT01204307 ·Status: COMPLETED ·Phase: PHASE2
-
Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC
NCT06300424 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Phase III Trial of SYS6010 Versus Platinum-based Chemotherapy for EGFR-mutated NSCLC(SYNSTAR01)
NCT06927986 ·Status: RECRUITING ·Phase: PHASE3
-
A Study of Sequential Therapy of Camrelizumab Combined With Chemotherapy(Irinotecan Plus Platinum)and With Apatinib in Participants With Untreated Advanced Small Cell Lung Cancer(SCLC)
NCT04453930 ·Status: UNKNOWN ·Phase: PHASE2
-
Pemetrexed vs Pemetrexed Plus Cisplatin in EGFR-mutant NSCLC Patients After First Line EGFR-TKIs Failure
NCT02725918 ·Status: UNKNOWN ·Phase: PHASE2
-
Gefitinib With Chemotherapy or Anti-angiogenesis in NSCLC Patients With Bim Deletion or Low EGFR Mutation Abundance
NCT03267654 ·Status: UNKNOWN ·Phase: PHASE2
-
Sintilimab Combined With Anlotinib Therapy for Initially Unresectable Non-small Cell Lung Cancer
NCT05306847 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Neoadjuvant Icotinib With Chemotherapy for Epidermal Growth Factor Receptor(EGFR)-Mutated Resectable Lung Adenocarcinoma
NCT05132985 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma
NCT01565538 ·Status: COMPLETED ·Phase: PHASE2
-
Double Dose of Third-generation EGFR-TKI Plus Intrathecal Pemetrexed Versus Double Dose of Third-generation EGFR-TKI in Patients With LM Progression Following the Treatment of Routine Dose of Third-generation EGFR-TKI
NCT06441045 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Alternating Icotinib and Chemotherapy for Advanced Non-small Cell Lung Cancer With EGFR Mutation
NCT02737774 ·Status: UNKNOWN ·Phase: PHASE2