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Hope for Drug-Resistant lung cancer: new combo trials underway

NCT ID NCT02143466

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Updated 2 times

Summary

This study tests two different drug combinations in people with advanced EGFR-mutant lung cancer whose disease has worsened after standard targeted therapy. Participants receive either osimertinib plus savolitinib or osimertinib plus selumetinib. The main goal is to check safety and find the right doses, while also looking for early signs that the tumors shrink.

What this could mean

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

Active substance
Osimertinib (AZD9291) combined with savolitinib (AZD6094) or selumetinib
What this could lead to
If successful, this could point toward new combination treatments for advanced lung cancer that has stopped responding to standard targeted therapy.
What could go wrong
This is an early-phase trial focused on safety and dosing, so it is too soon to know if these combinations will work better than existing options. Side effects from combining drugs are also unknown.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

344 people

The number who actually took part.

Started

Aug 2014

Expected to finish

Dec 2026

An estimate. End dates often move.

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 Signed informed consent Male or female aged at least 18 years and older. Patients from Japan aged at least 20 years. Histological or cytological confirmation of EGFRm+ NSCLC. Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including exon 19 deletion and L858R). Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI eg, gefitinib or erlotinib. These patients must have radiological progression (as per site assessment) on the last treatment administered prior to enrolling in the study. At least one lesion, not previously irradiated, not biopsied during the screening period, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes which must have short axis ≥15 mm) with computerised tomography (CT) or magnetic resonance imaging (MRI) which is suitable for accurate repeated measurements. Adequate haematological, liver and renal function as well as coagulation parameters. ECOG/WHO performance status of 0 or 1 or KPS \>80. Ability to swallow and retain oral medications. Prior to study entry, local confirmation of tumour cMET status is acceptable, a central result will be confirmed retrospectively. Local confirmation of tumour T790M status is acceptable if performed with an approved test and agreed by AstraZeneca. Agree to use adequate contraceptive measures. Exclusion Criteria Treatment with an EGFR TKI within approximately 5x half-life (eg, within 8 days for erlotinib, gefitinib or afatanib, or within 10 days for dacomitinib) of the first dose of study treatment. Any cytotoxic chemotherapy, investigational agents or other anticancer drugs for the treatment of advanced NSCLC from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment Patients currently receiving medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 weeks prior). For AZD6094 patients currently receiving prior to receiving the first dose, medications known to be strong inhibitors of CYP1A2. Prior AZD9291 dosing in the present study. Prior treatment with a 3rd generation (T790M-directed) therapy (eg, AZD9291, rociletinib or HM61713) outside of this study is permitted if allocated to the 3rd generation EGFR TKI cohort. Prior or current treatment with AZD6094 or another cMET inhibitor (eg, foretinib, crizotinib, cabozantinib, onartuzumab) if allocated to AZD9291 plus AZD6094 combination. Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation which must be completed within ≥4 weeks of the first dose of study treatment Major surgical procedure, or significant traumatic injury within 4 weeks of the first dose of study treatment, or have an anticipated need for major surgery during the study. Currently receiving treatment with warfarin sodium. LMWH is allowed. Active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy Any of the following cardiac diseases currently or within the last 6 months: Unstable angina pectoris, Congestive heart failure (NYHA ≥ Grade 2), Acute myocardial infarction, Stroke or transient ischemic attack. Known hypersensitivity to the active or inactive excipients of AZD6094. Uncontrolled hypertension (BP ≥150/95 mmHg despite medical therapy) Mean resting correct QT interval (QTcF) \>470 msec for women and \>450 msec for men or factors that may increase the risk of QTcF prolongation such as chronic hypokalaemia not correctable with supplements, congenital or familial long QT syndrome, or family history of unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval and cause Torsade de Pointes. Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiograms (ECGs), e.g. complete left bundle branch block, third degree heart block, second degree heart block, PR interval \>250 msec. Serious underlying medical condition at the time of treatment that would impair the ability of the patient to receive protocol treatment. Active hepatitis B (positive HBsAg result) or hepatitis C (HCV). Patients with a past or resolved HBV infection are eligible if negative for HBsAg and positive for anti-HBc or positive for HBsAg, but for \> 6 months have had normal transaminases and HBV DNA levels between 0-2000 IU/ml (inactive carrier state) and willing to start and maintain antiviral treatment for at least the duration of the study. HBV DNA levels \> 2000 IU/ml but on prophylactic antiviral treatment for the past 3 months and will maintain the antiviral treatment during the study. Patients with positive HCV antibody are eligible only if the polymerase chain reaction is negative for HCV RNA. Known serious active infection including, but not limited to, tuberculosis, or human immunodeficiency virus (positive HIV 1/2 antibodies). Presence of other active cancers, or history of treatment for invasive cancer, within the last 5 years. Patients with Stage I cancer who have received definitive local treatment at least 3 years previously, and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e., non-invasive) are eligible, as are patients with history of non-melanoma skin cancer. Women who are either pregnant or breast feeding. Previous allogeneic bone marrow transplant Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.

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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.

Advanced non-small cell lung cancer

Contacts and locations

Locations

  • Research Site

    Atlanta, Georgia, 30329, United States

  • Research Site

    Boston, Massachusetts, 02114, United States

  • Research Site

    Boston, Massachusetts, 02215, United States

  • Research Site

    New York, New York, 10065, United States

  • Research Site

    Philadelphia, Pennsylvania, 19111, United States

  • Research Site

    Nashville, Tennessee, 37232, United States

  • Research Site

    Calgary, Alberta, T2N 4N2, Canada

  • Research Site

    Edmonton, Alberta, T6G 1Z2, Canada

  • Research Site

    Chūōku, 104-0045, Japan

  • Research Site

    Habikino-shi, 583-8588, Japan

  • Research Site

    Hirakata-shi, 573-1191, Japan

  • Research Site

    Kashiwa, 227-8577, Japan

  • Research Site

    Nagoya, 460-0001, Japan

  • Research Site

    Nagoya, 464-8681, Japan

  • Research Site

    Gdansk, 80-952, Poland

  • Research Site

    Krakow, 31-202, Poland

  • Research Site

    Olsztyn, 10-357, Poland

  • Research Site

    Poznan, 60-569, Poland

  • Research Site

    Warsaw, 02-781, Poland

  • Research Site

    Chelyabinsk, 454087, Russia

  • Research Site

    Krasnoyarsk, 660133, Russia

  • Research Site

    Moscow, 115478, Russia

  • Research Site

    Omsk, 644013, Russia

  • Research Site

    Saint Petersburg, 195271, Russia

  • Research Site

    Saint Petersburg, 197002, Russia

  • Research Site

    Saint Petersburg, 197022, Russia

  • Research Site

    Saint Petersburg, 197342, Russia

  • Research Site

    Saint Petersburg, 197758, Russia

  • Research Site

    Cheongju-si, 28644, South Korea

  • Research Site

    Goyang-si, 10408, South Korea

  • Research Site

    Seongnam-si, 13620, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Kaohsiung City, 82445, Taiwan

  • Research Site

    Kaohsiung City, 83301, Taiwan

  • Research Site

    Tainan, 704, Taiwan

  • Research Site

    Taipei, 10002, Taiwan

  • Research Site

    Taipei, 112, Taiwan

  • Research Site

    Taipei, 235, Taiwan

  • Research Site

    Kyiv, 03022, Ukraine

  • Research Site

    Vinnytsia, 21029, Ukraine

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