Icotinib With Concurrent Radiotherapy vs. Chemoradiotherapy in Non-small Cell Lung Cancer

People's Hospital of Guangxi

Status and phase: Unknown; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Carboplatin; Drug: Icotinib; Radiation: Thoracic radiotherapy(TRT); Drug: Pemetrexed

Study type: Interventional

Funder types: Other

Identifiers

NCT02407366

FGSLC-2015

Details and patient eligibility

About

The current standard of care for unresectable locally advanced non-small-cell lung cancer (NSCLC) is a combination of chemotherapy and thoracic radiotherapy (TRT). The standard regimens consist of platinum-based doublet chemotherapy.Icotinib(BPI-2009, Conmana) is the first self-developed small molecular drug in China for targeted therapy of lung cancer.Icotinib is a novel oral quinazoline compound that has proven survival benefit in Chinese patients with lung cancer,especially in EGFR mutation lung cancer. This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus pemetrexed + carboplatin with concurrent radiotherapy in inoperable stage III non-small cell lung cancer with EGFR mutation, the primary endpoint is progression-free survival.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation.
2. No previous systemic anticancer therapy.
3. life expectancy more than three months.
4. ECOG Performance Status of 0 to 1.
5. Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
6. Patients will be required to provide informed consent before enrollment.

Exclusion criteria

1. Intrapulmonary metastasis, atelectasis of an entire hemithorax,pleural dissemination, or contralateral hilar lymph node metastasis.
2. Prior chemotherapy for NSCLC, chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway.
3. Severe heart disease, uncontrolled diabetes mellitus, or active infection.
4. Active concomitant malignancy, and pregnancy or breast-feeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Icotinib with concurrent radiotherapy

Experimental group

Description:

Icotinib (125 mg ,three times daily)with concurrent thoracic radiotherapy(TRT) (66 Gy/33 fractions), followed by maintenance icotinib (125 mg ,Three times daily) until disease progression or unacceptable toxicity.

Treatment:

Radiation: Thoracic radiotherapy(TRT)

Drug: Icotinib

Chemoradiotherapy

Active Comparator group

Description:

Pemetrexed(500mg/m2) + carboplatin (AUC，5) every 21 days for three cycles with concurrent thoracic radiotherapy(TRT) (66 Gy/33 fractions), followed by consolidation chemotherapy with two cycles of pemetrexed(500mg/m2) + carboplatin (AUC，5) every 21 days.Maintenance pemetrexed(500mg/m2) will be administered after consolidation chemotherapy until disease progression or unacceptable toxicity .

Treatment:

Radiation: Thoracic radiotherapy(TRT)

Drug: Pemetrexed

Drug: Carboplatin