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This is a phase II, single-arm study to evaluate the efficacy and safety of Afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.
This single-arm, open-label, prospective phase II clinical trial was designed to evaluate the efficacy and safety of afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.
The primary endpoint was the rate of NSCLC converting to resectable tumors. The secondary endpoints included R0 resection rate, major pathological response (MPR) rate, pathological complete response (pCR) rate, tumor downstaging rate, objective response rate (ORR), disease control rate (DCR), 1-year event-free survival (EFS) rate, EFS and overall survival (OS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Afatinib plus chemotherapy | Experimental | Patients with unresectable EGFR sensitive mutation-positive stage III NSCLC will receive 3-4 cycles of afatinib plus chemotherapy as the conversion treatment (afatinib 40mg qd; carboplatin (AUC 5) on day 1, and pemetrexed (500 mg/m2 for non-squamous carcinoma) or nab-paclitaxel (260 mg/m2 for squamous carcinoma) d1 q3w), and then surgery will be provided for patients who are suitable for primary tumor resection. Maintenance treatment with afatinib 40mg qd will continue up to 2 years or disease progression after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afatinib plus chemotherapy as conversion treatment | Drug | Patients with unresectable EGFR sensitive mutation-positive stage III NSCLC will receive 3-4 cycles of afatinib plus chemotherapy as the conversion treatment, and then surgery will be provided for patients who are suitable for primary tumor resection. |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of NSCLC converting to resectable tumors | The proportion of unresectable NSCLC patients who are converted to being suitable for surgery after 3-4 cycles afatinib plus chemotherapy. | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | The proportion of R0 resection in patients who receive surgery | immediately after the surgery |
| Major pathologic response (MPR) Rate | The proportion of patients who achieve MRP among those receiving surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hua Zhang, PhD | Contact | 0531-83347512 | 95192789@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Hua Zhang, PhD | Shandong Public Health Clinical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Public Health Clinical Center | Recruiting | Jinan | Shangdong | 250000 | China |
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|
| Up to 12 weeks |
| Pathologic complete response (pCR) Rate | The proportion of patients who achieve pCR among those receiving surgery | Up to 12 weeks |
| Tumor downstaging rate | The proportion of patients who reach the successful downstaging criteria for NSCLC | Up to 12 weeks |
| Objective response rate (ORR) | The proportion of patients who have a complete response (CR) or partial response (PR). | Up to five years |
| Disease control rate (DCR) | The proportion of patients who have a best overall response of CR, PR, or stable disease (SD). | Up to five years |
| Event-free survival (EFS) | The length of time after initial administration the patient remains free of recurrence/progression or death, whatever the cause. | Up to five years |
| The 2-year progression-free survival (PFS) rate | The proportion of patients who are event-free. | Up to two years |
| Overall Survival (OS) | The length of time after initial administration the patient remains alive | Up to five years |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077716 | Afatinib |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
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