Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for lung cancer patients: experimental drug shrinks tumors after other treatments fail

NCT ID NCT01802632

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called AZD9291 in 603 people with advanced non-small cell lung cancer whose tumors had started growing again after previous targeted therapy. The main goals were to find the safest and most effective dose, measure how the drug moves through the body, and see if it could shrink tumors. The results helped decide the best dose for future studies.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

603 people

The number who actually took part.

Started

Mar 2013

Finished

Dec 2023

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: * Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses * Aged at least 18 years. Patients from Japan aged at least 20 years. * Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer (NSCLC). * Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI e.g. gefitinib or erlotinib (with the exception of 1st line expansion cohort). In addition other lines of therapy may have been given. All patients must have documented radiological progression on the last treatment administered prior to enrolling in the study. * Patients (with the exception of 1st line expansion cohort) must fulfil one of the following: * Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) OR * Must have experienced clinical benefit from EGFR TKI, according to the Jackman criteria (Jackman et al 2010) followed by systemic objective progression (RECIST or WHO) while on continuous treatment with EGFR TKI. * Previous treatment with a single-agent EGFR TKI (e.g. gefitinib or erlotinib). * Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing or evidence of non-child bearing potential. * Male patients should be willing to use barrier contraception. * For 1st Line expansion cohort ONLY, confirmation that the tumour is EGFRm+ve and have had no prior therapy for their advanced disease (for 1st line patients biopsy will be at time of diagnosis of advanced disease). * For dose expansion and extension cohorts, patients must also have confirmation of tumour T790M mutation status (confirmed positive or negative) from a biopsy sample taken after disease progression on the most recent treatment regimen (irrespective of whether this is EGFR TKI or chemotherapy). Prior to entry a result from the central analysis of the patient's T790M mutation status must be obtained. \- World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks. Exclusion Criteria: * Treatment with an EGFR TKI (erlotinib or gefitinib) within 8 days (approximately 5x half-life) of the first dose of study treatment. * Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from the treatment of advanced NSCLC from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment. * AZD9291 in the present study (ie, dosing with AZD9291 previously initiated in this study). * Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection. * 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced (inoperable) non small cell lung cancer are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

neoplasm Neoplasm Metastasis non-small cell lung carcinoma

As listed by the trial registrant

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

Advanced (inoperable) non small cell lung cancer Advanced non-small cell lung cancer

Contacts and locations

Locations

  • Research Site

    Aurora, Colorado, 80045, United States

  • Research Site

    Atlanta, Georgia, 30322, United States

  • Research Site

    Boston, Massachusetts, 02114, United States

  • Research Site

    Boston, Massachusetts, 02215, United States

  • Research Site

    Charlotte, North Carolina, 28204, United States

  • Research Site

    Nashville, Tennessee, 37232, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Heidelberg, 3084, Australia

  • Research Site

    Kogarah, 2217, Australia

  • Research Site

    Nedlands, 6009, Australia

  • Research Site

    Pierre-Bénite, 69310, France

  • Research Site

    Saint-Herblain, 44805, France

  • Research Site

    Villejuif, 94800, France

  • Research Site

    Cologne, 50924, Germany

  • Research Site

    Essen, 45122, Germany

  • Research Site

    Würzburg, 97080, Germany

  • Research Site

    Genova, 16100, Italy

  • Research Site

    Orbassano, 10043, Italy

  • Research Site

    Roma, 00144, Italy

  • Research Site

    Chiba, 260-8717, Japan

  • Research Site

    Fukuoka, 811-1395, Japan

  • Research Site

    Fukuoka, 812-8582, Japan

  • Research Site

    Habikino-shi, 583-8588, Japan

  • Research Site

    Hirakata-shi, 573-1191, Japan

  • Research Site

    Hiroshima, 730-8518, Japan

  • Research Site

    Kanazawa, 920-8641, Japan

  • Research Site

    Kashiwa, 227-8577, Japan

  • Research Site

    Kobe, 650-0047, Japan

  • Research Site

    Matsuyama, 790-0007, Japan

  • Research Site

    Okayama, 700-8558, Japan

  • Research Site

    Shinjuku-ku, 160-0023, Japan

  • Research Site

    Sunto-gun, 411-8777, Japan

  • Research Site

    Takatsuki-shi, 569-8686, Japan

  • Research Site

    Yokohama, 221-0855, Japan

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 6351, South Korea

  • Research Site

    Madrid, 08035, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Seville, 41013, Spain

  • Research Site

    Tainan, 704, Taiwan

  • Research Site

    Taipei, 10002, Taiwan

  • Research Site

    Manchester, M20 4BX, United Kingdom

  • Research Site

    Newcastle upon Tyne, NE7 7DN, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.