Phase II Single Arm Study of AZD9291 to Treat NSCLC Patients in Asia Pacific

NCT02442349 | Completed Phase 2 Results

• 1 other identifier: D5160C00017
• Study Type: interventional
• Target: 171
• Locations: 3 countries
• Sites: 30

Brief Summary

A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in Asia Pacific Patients with Locally Advanced/Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene

Conditions

Non-Small Cell Lung Cancer

Keywords

Phase II, Open Label, Single-arm study, Safety and Efficacy of AZD9291, Asia Pacific, NSCLC with T790M mutation within the Epidermal Growth Factor Receptor Gene

Outcome Measures

Primary Outcomes (1)

• ORR According to RECIST 1.1 by Independent Review

  Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.

  At baseline and every 6 weeks from time of first dose until objective disease progression,up to 24 months after Last Patient First Dose(LPFD)

Secondary Outcomes (5)

• DoR According to RECIST 1.1 by Independent Review

  At baseline and every 6 weeks from time first dose until date of progression, up to 24 months after LPFD.

• DCR According to RECIST 1.1 by Independent Review

  At baseline and every 6 weeks from time first dose until date of progression, up to 24 months after Last Patient First Dose(LPFD)

• Tumour Shrinkage According to RECIST 1.1 by Independent Review

  At baseline and every 6 weeks from time of first dose until date of progression, up to 24 months after LPFD.

• PFS According to RECIST 1.1 by Independent Review

  At baseline and every 6 weeks from time of first dose until objective disease progression, up to 24 months after LPFD.

• Overall Survival (OS)

  From first dose to end of study or date of death from any cause, whichever comes first, assessed every 6 weeks up to approximately 95 OS events (about 55% maturity) have been observed out of all enrolled patients.

Study Arms (1)

AZD9291

EXPERIMENTAL

Once daily tablet 80 mg

Drug: AZD9291

Interventions

AZD9291 DRUG

Once daily tablet 80 mg

AZD9291

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged at least 18 years. Patient from Asia Pacific will be enrolled only.
• Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
• Radiological documentation of disease progression on the last treatment administered prior to enrolling in the study: following 1st line EGFR TKI treatment but who have not received further treatment OR following prior therapy with an EGFR TKI and a platinum-based doublet chemotherapy. Patients may have also received additional lines of treatment.
• Documented EGFR mutation (at any time since the initial diagnosis of NSCLC) known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q).
• Patients must have central confirmation of tumour T790M mutation positive status from a biopsy sample taken after confirmation of disease progression on the most recent treatment regimen.
• World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
• At least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline as ≥10mm in the longest diameter (except lymph nodes which must have short axis ≥15mm) with computerised tomography (CT) or magnetic resonance imaging (MRI) which is suitable for accurate repeated measurements.
• Females of child-bearing potential using contraception and must have a negative pregnancy test.

You may not qualify if:

• Treatment with an EGFR-TKI (eg, erlotinib, gefitinib, icotinib or afatinib) within 8 days or approximately 5x half-life of study entry; any cytotoxic chemotherapy, investigational agents or other anticancer drugs within 14 days of study entry; previous treatment with AZD9291 or a 3rd generation EGFR TKIs; Major surgery within 4 weeks of study entry; radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of study entry; currently receiving treatment with potent inhibitors or inducers of CYP3A4.
• Any unresolved toxicities from prior therapy.
• Unstable spinal cord compression or brain metastases.
• Severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses or infection.
• Refractory nausea and vomiting, chronic gastrointestinal diseases or bowel resection.
• Cardiac disease.
• Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
• Inadequate bone marrow reserve or organ function.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (30)

Research Site

Kogarah, 2217, Australia

Location

Research Site

Nedlands, 6009, Australia

Location

Research Site

Woolloongabba, 4102, Australia

Location

Research Site

Beijing, 100021, China

Location

Research Site

Beijing, 100142, China

Location

Research Site

Beijing, 100730, China

Location

Research Site

Changchun, 130000, China

Location

Research Site

Chengdu, 610041, China

Location

Research Site

Chongqing, 400038, China

Location

Research Site

Chongqing, 400042, China

Location

Research Site

Fuzhou, 350014, China

Location

Research Site

Haikou, 570311, China

Location

Research Site

Hangzhou, 310003, China

Location

Research Site

Hangzhou, 310006, China

Location

Research Site

Hangzhou, 310022, China

Location

Research Site

Harbin, 150049, China

Location

Research Site

Jinan, 250117, China

Location

Research Site

Nanjing, 210009, China

Location

Research Site

Shanghai, 200030, China

Location

Research Site

Shanghai, 200032, China

Location

Research Site

Shanghai, CN-200433, China

Location

Research Site

Wuhan, 430022, China

Location

Research Site

Wuhan, 430030, China

Location

Research Site

Xi'an, 710032, China

Location

Research Site

Xi'an, 710038, China

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Research Site

Zhengzhou, 450008, China

Location

Research Site

Goyang-si, 10408, South Korea

Location

Research Site

Seongnam-si, 13620, South Korea

Location

Research Site

Seoul, 05505, South Korea

Location

Research Site

Seoul, 6351, South Korea

Location

Related Links

• Redacted CSP

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Global Clinical Lead, Yuri Rukazenkov
• Organization: AstraZeneca

+441625231825

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 13, 2015
• Study Start: June 22, 2015
• Primary Completion: March 4, 2016
• Study Completion: November 28, 2025
• Last Updated: January 9, 2026
• Results First Posted: April 25, 2017

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

KR (4); AU (3); CN (23)