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New combo aims to stall lung cancer progression

NCT ID NCT03775486

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This Phase II trial tests whether adding olaparib to durvalumab helps keep stage IV non-small cell lung cancer from growing after initial chemotherapy. About 400 patients whose cancer did not worsen on standard chemo plus durvalumab will receive either the combination or durvalumab alone as maintenance. The main goal is to see how long the cancer stays controlled.

What this could mean

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

Active substance
durvalumab and olaparib
What this could lead to
If it works, this combination could help keep advanced lung cancer from progressing longer than durvalumab alone, offering a new maintenance option.
What could go wrong
This is a Phase II trial, so results are still early. The combination may not improve survival and could cause more side effects than the single drug.

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

401 people

The number who actually took part.

Started

Dec 2018

Expected to finish

Sep 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: \- Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation. Patients must have tumors that lack activating EGFR mutations and ALK fusions. * (WHO)/(ECOG) performance status of 0 or 1 * No prior chemotherapy or any other systemic therapy for Stage IV NSCLC * Adequate organ and marrow function without blood transfusions in the past 28 days, * At least 1 tumor lesion, not previously irradiated, that can be accurately measured as per RECIST 1.1. Key Inclusion criteria for randomization to maintenance treatment: * Documented radiographic evidence of CR, PR, or Stable Disease (SD) as per Investigator-assessed RECIST 1.1 following 4 cycles of platinum-based chemotherapy. * Creatinine Clearance (CrCl) ≥51 mL/min calculated by the investigator or designee using the Cockcroft-Gault equation or measured by 24-hour urine collection. * Ability to swallow whole oral medications. * All patients must provide a formalin-fixed, paraffin embedded tumor sample for tissue-based immunohistochemistry staining and DNA sequencing to determine PD-L1 expression, HRRm status, and other correlatives: either newly acquired or archival tumor samples (\<3 years old) are acceptable. If available, a newly acquired tumor biopsy, collected as part of routine clinical practice, is preferred. If not available, an archival sample taken \<3 years prior to screening is acceptable. If both an archival sample and a fresh tumor biopsy sample are available, both samples should be submitted for analysis and must be submitted as different samples using different accession numbers. Slides from different blocks cannot be mixed and submitted with the same kit. Exclusion criteria * Mixed small-cell lung cancer and sarcomatoid variant NSCLC histology. * Prior exposure to any chemotherapy agents (except chemotherapy or chemoradiation for non-metastatic disease), polyadenosine 5'diphosphoribose \[poly (ADP ribose)\] polymerase (PARP) therapy, or immunomediated therapy * Active or prior documented autoimmune or inflammatory disorders. * Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. * Current or prior use of immunosuppressive medication within 14 days before the first dose of Investigational Product (IP) * untreated (CNS) metastases and/or carcinomatous meningitis * Active infection. Exclusion criteria to be randomized to maintenance treatment: • Inability to complete 4 cycles of platinum-based chemotherapy for any reason or discontinuation of Durvalumab during initial therapy.

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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 (NSCLC)

Contacts and locations

Locations

  • Research Site

    Bonita Springs, Florida, 34135, United States

  • Research Site

    St. Petersburg, Florida, 33705, United States

  • Research Site

    Tallahassee, Florida, 32308-5304, United States

  • Research Site

    West Palm Beach, Florida, 33401, United States

  • Research Site

    Kansas City, Missouri, 64132, United States

  • Research Site

    Bethlehem, Pennsylvania, 18015, United States

  • Research Site

    Chattanooga, Tennessee, 37404, United States

  • Research Site

    Nashville, Tennessee, 37203, United States

  • Research Site

    Houston, Texas, 77090, United States

  • Research Site

    Aalst, 9300, Belgium

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Roeselare, 8800, Belgium

  • Research Site

    Budapest, 1088, Hungary

  • Research Site

    Budapest, 1122, Hungary

  • Research Site

    Debrecen, 4032, Hungary

  • Research Site

    Deszk, 6772, Hungary

  • Research Site

    Farkasgyepü, 8582, Hungary

  • Research Site

    Törökbálint, 2045, Hungary

  • Research Site

    Ahmedabad, 380009, India

  • Research Site

    Ahmedabad, 380053, India

  • Research Site

    Jamnagar, 361008, India

  • Research Site

    Kochi, 682026, India

  • Research Site

    Mysuru, 570021, India

  • Research Site

    Nashik, 422004, India

  • Research Site

    Nashik, 422009, India

  • Research Site

    Pune, 411001, India

  • Research Site

    Thiruvananthapuram, 695011, India

  • Research Site

    Chūōku, 104-0045, Japan

  • Research Site

    Kanazawa, 920-8641, Japan

  • Research Site

    Kurume-shi,, 830-0011, Japan

  • Research Site

    Matsuyama, 791-0280, Japan

  • Research Site

    Nagoya, 460-0001, Japan

  • Research Site

    Sendai, 980-0873, Japan

  • Research Site

    Sunto-gun, 411-8777, Japan

  • Research Site

    Ube-shi, 755-0241, Japan

  • Research Site

    Chihuahua City, 31200, Mexico

  • Research Site

    Culiacán, 80230, Mexico

  • Research Site

    San Luis Potosí City, 78250, Mexico

  • Research Site

    Blaricum, 1261, Netherlands

  • Research Site

    Harderwijk, 3844, Netherlands

  • Research Site

    Tilburg, 5022 GC, Netherlands

  • Research Site

    Bialystok, 15-540, Poland

  • Research Site

    Lodz, 90-302, Poland

  • Research Site

    Poznan, 60-693, Poland

  • Research Site

    Prabuty, 82-550, Poland

  • Research Site

    Arkhangelsk, 163045, Russia

  • Research Site

    Chelyabinsk, 454092, Russia

  • Research Site

    Kursk, 305524, Russia

  • Research Site

    Moscow, 115478, Russia

  • Research Site

    Nal'chik, 360000, Russia

  • Research Site

    P. Herzen Moscow Oncology Rese, 125284, Russia

  • Research Site

    Saint Petersburg, 197022, Russia

  • Research Site

    Sochi, 354000, Russia

  • Research Site

    Yaroslavl, 150054, Russia

  • Research Site

    Dongjakgu, 07061, South Korea

  • Research Site

    Goyang-si, 10408, South Korea

  • Research Site

    Seodaemun-gu, 03722, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Suweonsi Paldalgu, 16247, South Korea

  • Research Site

    Dnipro, 49102, Ukraine

  • Research Site

    Kharkiv Region, 61024, Ukraine

  • Research Site

    Kirovohrad, 25006, Ukraine

  • Research Site

    Odesa, 65055, Ukraine

  • Research Site

    Uzhhorod, 88000, Ukraine

  • Research Site

    Zaporizhzhya, 69059, Ukraine

  • Research Site

    Dundee, DD1 9SY, United Kingdom

  • Research Site

    Hull, HU6 7RX, United Kingdom

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