New pill shows promise for lung cancer patients with Hard-to-Treat mutation

NCT ID NCT02442349

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a daily pill called AZD9291 in 171 people from Asia Pacific with advanced lung cancer that has a specific genetic change (T790M mutation). The goal was to see if the drug could shrink tumors and control the disease after other treatments stopped working. Researchers measured how many patients had their tumors shrink significantly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: AZD9291 (osimertinib) - a targeted cancer drug taken as a daily tablet
What this could lead to: If successful, this could provide a new treatment option for lung cancer patients with a specific genetic mutation (T790M) whose disease has worsened after other therapies.
What could go wrong: This is a phase 2 trial with a small number of patients (171) and no comparison group, so results may not apply to everyone. The drug may not work for all patients and could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

171 people

The number who actually took part.

Started

Jun 2015

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

Research Site

Kogarah, 2217, Australia
Research Site

Nedlands, 6009, Australia
Research Site

Woolloongabba, 4102, Australia
Research Site

Beijing, 100021, China
Research Site

Beijing, 100142, China
Research Site

Beijing, 100730, China
Research Site

Changchun, 130000, China
Research Site

Chengdu, 610041, China
Research Site

Chongqing, 400038, China
Research Site

Chongqing, 400042, China
Research Site

Fuzhou, 350014, China
Research Site

Haikou, 570311, China
Research Site

Hangzhou, 310003, China
Research Site

Hangzhou, 310006, China
Research Site

Hangzhou, 310022, China
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Harbin, 150049, China
Research Site

Jinan, 250117, China
Research Site

Nanjing, 210009, China
Research Site

Shanghai, 200030, China
Research Site

Shanghai, 200032, China
Research Site

Shanghai, CN-200433, China
Research Site

Wuhan, 430022, China
Research Site

Wuhan, 430030, China
Research Site

Xi'an, 710032, China
Research Site

Xi'an, 710038, China
Research Site

Zhengzhou, 450008, China
Research Site

Goyang-si, 10408, South Korea
Research Site

Seongnam-si, 13620, South Korea
Research Site

Seoul, 05505, South Korea
Research Site

Seoul, 6351, South Korea

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