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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.
For patients with locally advanced unresectable or metastatic non-small cell lung cancers, 4-6 cycles of chemotherapy plus immunotherapy with immune maintenance therapy is currently the standard treatment. Short-course chemotherapy (2 cycles) combined with immunotherapy has been proved effective in some patients. Recently, circulating tumor DNA (ctDNA) has been detected in the cell-free component of peripheral blood samples in advanced non-small cell lung cancers and many other solid tumors. To identify the patients who can benefit from the short-course chemotherapy (2 cycles) combined with immunotherapy, dynamic monitoring of ctDNA in both 4-6 cycles and 2 cycles chemotherapy patients could be a promising alternative test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 cycles chemotherapy combined with PD-1/PD-L1 inhibitors | 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. |
| |
| 4-6 cycles chemotherapy combined with PD-1/PD-L1 inhibitors | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunotherapy | Drug | PD-1/PD-L1 inhibitors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in ctDNA Level Following Chemo-immunotherapy | Will be assessed for ctDNA levels at baseline, end of chemotherapy, and immunotherapy maintenance | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | From the date of treatment until the date of progression of lung cancer or death from any other cause assessed up to 12 months | up to 1 year |
| Overall survival | From the date of treatment until the date of death from any cause assessed up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Male or female aged over 18 years and under 80 years with locally advanced unresectable or metastatic non-small cell lung cancer, and no prior immunotherapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zongyang Yu, Ph.D | Contact | 13509327806 | yuzy527@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 900TH Hospital of Joint Logisti'cs Support Force | Fuzhou | Fujian | 350025 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| D000970 | Antineoplastic Agents |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D045506 | Therapeutic Uses |
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circulating tumor DNA (ctDNA) of peripheral blood samples
| Chemotherapeutic Agent | Drug | 2 cycles |
|
| Chemotherapy | Drug | 4~6 cycles |
|
| up to 24 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |