Clinical trial · Observational
ctDNA as a Biomarker for Treatment in Advanced NSCLC
A Prospective，Randomized, Multi-center Study to Identify the Patients Who Benefit From Short-course Chemotherapy (2 Cycles) in Combination With Immunotherapy as Treatment for Patients With Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer (TLUNG)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The dynamic monitoring of circulating tumor DNA aims to evaluate the response and progression-free survival of short-course chemotherapy (2 cycles) combined with immunotherapy in patients with locally advanced unresectable or metastatic non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapeutic Agent | Drug | — | UNRESOLVED |
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Immunotherapy | Drug | Immunotherapy | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- 2 cycles chemotherapy combined with PD-1/PD-L1 inhibitors
- description
- Participants receive 2 cycles chemotherapy combined with PD-1/PD-L1 inhibitors, after achieving CR/PR/SD according to RECIST v1.1, then will continue immune monotherapy maintenance therapy.
- interventionNames
- Drug: Immunotherapy
- Drug: Chemotherapeutic Agent
- label
- 4-6 cycles chemotherapy combined with PD-1/PD-L1 inhibitors
- description
- Participants receive 4\~6 cycles chemotherapy combined with PD-1/PD-L1 inhibitors, after achieving CR/PR/SD according to RECIST v1.1, then will continue immune monotherapy maintenance therapy.
- interventionNames
- Drug: Immunotherapy
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Change in ctDNA Level Following Chemo-immunotherapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * (1)Histologically confirmed non-small cell lung cancer; (2)Locally advanced unresectable or metastatic disease; (3)Male or female aged over 18 years and under 80 years; (4)Subjects must not have received any immunotherapy for advanced lung cancer, and have an estimated life expectancy of more than 12 weeks (5)Eastern Cooperative Oncology Group (ECOG) score as 0 \~ 1; (6)No EGFR mutation, ALK or ROS1 rearrangement; (7)Adequate tumor tissue for PD-L1 testing; (8)With at least one measurable lesion confirmed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)； (9)The subjects must sign the informed consent, indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study. Exclusion Criteria: * (1)Serious immune-related adverse events occurred; (2)Participation in other clinical study; (3)With the history of autoimmune disease or immunodeficiency disease; (4)History of another primary malignancy within 5 years; (5)Without complete clinical information; (6)Pregnant or lactating women; (7)Other conditions in which the investigator believes that the patient should not participate in this trial.
References
Publications (0)
Data not yet available