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

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Icotinib; Drug: Pemetrexed; Radiation: Thoracic radiotherapy(TRT); Drug: Carboplatin

• Registration Number: NCT02407366
• Lead Sponsor: People's Hospital of Guangxi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Status Verified: 2015-03
• Study First Submitted: 2015-03-25
• Study First Submitted QC: 2015-03-30
• Last Update Submitted: 2015-03-30
• Study First Posted: 2015-04-02
• Last Update Posted: 2015-04-02
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Icotinib with concurrent radiotherapy	Thoracic radiotherapy(TRT)	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.
Chemoradiotherapy	Thoracic radiotherapy(TRT)	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 .
Icotinib with concurrent radiotherapy	Icotinib	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.
Chemoradiotherapy	Carboplatin	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 .
Chemoradiotherapy	Pemetrexed	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 .

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	One year	A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.

Secondary Outcome Measures

Name	Time	Method
Objective response rate	two years	Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Overall survival(OS)	two years	Overall survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.
Quality of life	two years	Quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) questionnaire.
Adverse events	two years	The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.

Trial Locations

Locations (1)

The people's Hospital of the Guangxi Zhuang Autonomous Region; 🇨🇳 Nanning, Guangxi, China