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Can adding a targeted pill to chemo beat resistant lung cancer?

NCT ID NCT04765059

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 08, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether adding the targeted drug osimertinib to standard chemotherapy can help people with advanced EGFR-mutant non-small cell lung cancer whose disease has progressed after initial osimertinib treatment. About 98 participants will receive either osimertinib plus chemo or a placebo plus chemo. The main goal is to see if the combination delays cancer growth.

What this could mean

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

Active substance
Osimertinib (a targeted cancer pill) combined with chemotherapy (pemetrexed plus cisplatin or carboplatin)
What this could lead to
If successful, this could offer a new treatment option for people with EGFR-mutant lung cancer whose disease has worsened after initial osimertinib therapy.
What could go wrong
This is a relatively small Phase 3 trial (98 participants) and results may not apply to all patients. Adding osimertinib to chemo may increase side effects without improving outcomes.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

98 people

The number who actually took part.

Started

Sep 2021

Expected to finish

Jun 2027

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: 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol. 2. Pathologically confirmed non-squamous NSCLC. 3. Locally advanced (clinical stage IIIB or IIIC) or metastatic NSCLC (clinical stage IVA or IVB) or recurrent NSCLC, not amenable to curative surgery or radiotherapy. 4. Evidence of radiological extracranial disease progression following (Investigator-assessed) response or SD for ≥ 6 months during first-line osimertinib treatment, but who have not received further, subsequent treatment. 5. Tumor known to harbor 1 of the 2 or both common epidermal growth factor receptor (EGFR) mutations known to be associated with EGFR tyrosine kinase inhibitor (TKI) sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations, which may include T790M. 6. World Health Organization performance status of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks. 7. Life expectancy \>12 weeks at Day 1. 8. At least 1 lesion, not previously irradiated, that can be accurately measured. 9. Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of childbearing potential, or must have evidence of non-childbearing potential by fulfilling criteria at screening. 10. Male patients must be willing to use barrier contraception Exclusion Criteria: 1. Clinical or radiological evidence of CNS progression on first-line osimertinib. 2. Past medical history of interstitial lung disease (ILD)/pneumonitis, drug-induced ILD/pneumonitis, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD/pneumonitis. 3. Any evidence of severe or uncontrolled systemic diseases. 4. Any of the following cardiac criteria: i) Mean resting QTc \>470 msec ii) Any clinically important abnormalities in rhythm, conduction, or morphology of resting electrocardiogram iii) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events 5. Any concurrent and/or other active malignancy that has required treatment within 2 years of first dose of investigational product (IP). 6. Any unresolved toxicities from prior therapy. 7. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib. 8. More than 4 weeks elapsed since last dose of osimertinib by date of randomization. 9. Unable to tolerate osimertinib 80 mg first-line therapy. 10. Prior treatment with any systemic anti-cancer therapy. 11. Major surgery within 4 weeks of the first dose of IP. 12. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of IP. 13. Current use of medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP) 3A4. 14. Participation in another clinical study with an IP other than first-line osimertinib during the 4 weeks prior to Day 1.

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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

    Silver Spring, Maryland, 20910, United States

  • Research Site

    Boston, Massachusetts, 02114, United States

  • Research Site

    Beijing, 100005, China

  • Research Site

    Beijing, 100142, China

  • Research Site

    Ganzhou, 341099, China

  • Research Site

    Guangzhou, 510080, China

  • Research Site

    Jinan, 250013, China

  • Research Site

    Shenyang, 110001, China

  • Research Site

    Tianjin, 300060, China

  • Research Site

    Zhengzhou, 450008, China

  • Research Site

    Berlin, 12351, Germany

  • Research Site

    Cologne, 50937, Germany

  • Research Site

    Cologne, 51109, Germany

  • Research Site

    Hanover, 30625, Germany

  • Research Site

    München, D-80336, Germany

  • Research Site

    Beersheba, 84101, Israel

  • Research Site

    Jerusalem, 9103102, Israel

  • Research Site

    Jerusalem, 9112001, Israel

  • Research Site

    Kfar Saba, 4428164, Israel

  • Research Site

    Tel Aviv, 6423906, Israel

  • Research Site

    Tel Litwinsky, 52621, Israel

  • Research Site

    Florence, 50134, Italy

  • Research Site

    Meldola, 47014, Italy

  • Research Site

    Messina, 98158, Italy

  • Research Site

    Naples, 80131, Italy

  • Research Site

    Padova, 35128, Italy

  • Research Site

    Roma, 00168, Italy

  • Research Site

    Terni, 05100, Italy

  • Research Site

    Verona, 37124, Italy

  • Research Site

    Alicante, 03010, Spain

  • Research Site

    Barcelona, 08907, Spain

  • Research Site

    Córdoba, 14004, Spain

  • Research Site

    León, 24071, Spain

  • Research Site

    Madrid, 28040, Spain

  • Research Site

    Málaga, 29010, Spain

  • Research Site

    Murcia, 30008, Spain

  • Research Site

    Oviedo, 33011, Spain

  • Research Site

    Palma de Mallorca, 07010, Spain

  • Research Site

    Seville, 41013, Spain

  • Research Site

    Valencia, 46010, Spain

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