PROPHET Study: ctDNA-Guided Personalized Induction Immunochemotherapy for NSCLC
NCT06977074 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83
Last updated 2025-05-23
Summary
The goal of this clinical trial is to evaluate the clinical value of ctDNA testing in guiding the optimization of immunochemotherapy cycles during induction treatment for resectable patients with NSCLC. The main questions it aims to answer are:
* Does ctDNA clearance indicate pathological complete response?
* Are additional cycles of immunochemotherapy necessary for patients who have ctDNA clearance after initial cycles of treatment? Researchers will use ctDNA dynamics to guide the cycles of induction treatment to see if some patients can avoid excessive cycles of treatment.
Conditions
- Non-small Cell Lung Cancer (NSCLC)
Interventions
- DRUG
-
PD-1 inhibitor
Two to four cycles of tislelizumab at a dose of 200 mg every three weeks, along with a platinum-based chemotherapy doublet based on the result of ctDNA dynamics
- DRUG
-
Platinum Doublet
Platinum-based chemotherapy (carboplatin AUC=5 + pemetrexed 500 mg/m² \[adenocarcinoma\] or nab-paclitaxel 260 mg/m² \[squamous/other subtypes\])
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Ting Zhou · Sun Yat-sen University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-10
- Primary Completion
- 2028-05-10
- Completion
- 2030-05-10
Countries
- China
Study Locations
More Related Trials
-
Safety and Efficacy Evaluation of Serplulimab Plus Chemo in SCLC Transformed From EGFR-mutated NSCLC After Treatment
NCT05957510 ·Status: RECRUITING ·Phase: PHASE2
-
Alternating Icotinib and Chemotherapy for Advanced Non-small Cell Lung Cancer With EGFR Mutation
NCT02737774 ·Status: UNKNOWN ·Phase: PHASE2
-
Phase 2 Study of Pyrotinib in Previously Treated Patients With NSCLC Having EGFR or ERBB2 Exon 20 Insertion Mutation
NCT04063462 ·Status: UNKNOWN ·Phase: PHASE2
-
Neoadjuvant and Adjuvant Targeted Treatment in NSCLC With BRAF V600 or MET Exon 14 Mutations
NCT06054191 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
QL1706 Combined With Chemotherapy in the Treatment of Immune-mediated NSCLC
NCT07330596 ·Status: RECRUITING ·Phase: PHASE2
-
Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Advanced NSCLC
NCT02194556 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study of Icotinib With Chemotherapy as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer
NCT05104788 ·Status: RECRUITING ·Phase: PHASE2
-
Study of Chemotherapy Plus Icotinib to Treat EGFR Mutation-positive Non-small-cell Lung Cancer
NCT02272127 ·Status: UNKNOWN ·Phase: PHASE2
-
A Clinica Study of Pyrotinib in Patients of Advanced Non-Small Cell Lung Cancer With HER2 Mutation
NCT02834936 ·Status: COMPLETED ·Phase: PHASE2
-
A Single-Arm, Phase Ⅰb Study of Golidocitinib Combined With Anti-PD-1 for the Treatment of Previously Treated NSCLC
NCT06690671 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
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
-
A Study Comparing AC0010 and Chemotherapy in Patients With Advanced NSCLC Who Have Progressed Following Prior EGFR TKI
NCT03058094 ·Status: WITHDRAWN ·Phase: PHASE3
-
High-dose Icotinib Treatment Beyond Progression in EGFR Mutant NSCLC
NCT02960607 ·Status: UNKNOWN ·Phase: PHASE2
-
Surufatinib Combined With Toripalimab and Chemotherapy in the Treatment of Non-Small Cell Lung Cancer
NCT05003037 ·Status: UNKNOWN ·Phase: PHASE2
-
Efficacy of Gefitinib for Brain Metastasis of Non-Small Cell Lung Cancer
NCT00614809 ·Status: UNKNOWN ·Phase: PHASE2
-
Savolitinib Plus Docetaxel as 2L in EGFR/ALK/ROS1/MET ex14m-wildtype NSCLC With MET Overexpression
NCT05777278 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Evaluate EGFR Mutation Status and Impact Factors in North China
NCT02620657 ·Status: COMPLETED
-
S1 vs.Pemetrexed Plus Carboplatin in Patients With EGFR Wild Type Stage IIIB or IV Nonsquamous NSCLC
NCT02631460 ·Status: UNKNOWN ·Phase: PHASE2
-
Induction Erlotinib Therapy in Stage III A (N2) Non-Small Cell Lung Cancer (NSCLC)
NCT00600587 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Chemotherapy Sequenced by or Combined With EGFR-TKIs for NSCLC Patients Failed to EGFR-TKIs Therapy
NCT01746277 ·Status: UNKNOWN ·Phase: PHASE2
-
Neoadjuvant Chemotherapy Sequentially Combined with Sintilimab in Resectable EGFR-Mutant NSCLC
NCT06688656 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Phase II Clinical Study of Befotertinib in EGFR Non-classical Mutant NSCLC
NCT06863506 ·Status: RECRUITING ·Phase: PHASE2
-
Phase II Clinical Study of Pyrotinib in First-line Treatment of Primary HER2-amplified/Mutated Advanced Non-small Cell Lung Cancer
NCT05751018 ·Status: RECRUITING ·Phase: PHASE2
-
Third-line Treatment of Gefitinib in NSCLC Patients
NCT01933347 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase II Study of SSGJ-707 Monotherapy in First-line PD-L1 Positive Advanced NSCLC Patients
NCT06361927 ·Status: RECRUITING ·Phase: PHASE2