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New combo therapy aims to keep advanced lung cancer in check

NCT ID NCT03923270

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-phase trial tests whether adding chest radiation followed by immunotherapy drugs (durvalumab alone or with tremelimumab or olaparib) can help control extensive-stage small cell lung cancer after initial chemotherapy. About 25 adults whose cancer did not worsen after first-line treatment will participate. The main goals are to check safety and see how long the cancer stays controlled.

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

25 people

The number who actually took part.

Started

Jun 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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 * Body weight greater than 30 kg * Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study. * Participants must have small cell lung cancer, documented by histology or cytology from brushing, washing, fine needle aspiration or core biopsy from a defined lesion, but not from sputum cytology alone. No mixed histologies allowed. * Participants must be presented at initial diagnosis with extensive-stage disease (ES-SCLC). * Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1. * Participants must have received 4-6 cycles of platinum-based first-line chemotherapy and must have an ongoing complete response (CR), partial response (PR), or stable disease (SD) after completion. Acceptable combinations (NCCN guidelines), include cisplatin or carboplatin with etoposide or irinotecan. As an exception to the above criterion, participants receiving only 3 cycles of chemotherapy due to toxicity are eligible, if they have an ongoing PR or CR after the 3rd cycle. Participants who have received \> 6 cycles of platinum-based first-line chemotherapy are not eligible. Participants receiving checkpoint inhibitor (CPI) monotherapy (anti-PD-1, anti-PD-L1, others) as part of their first line chemotherapy treatment will be eligible as long as they discontinue the CPI prior to the start of thoracic radiotherapy. * Participants must initiate study treatment with thoracic XRT ≤ 60 days from the last dose of platinum- based first line chemotherapy; * Whenever possible, a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or 5-10 unstained slides of tumor sample (archival) should be made available (less material is acceptable); * Participants must have a life expectancy of 16 weeks or more. * Active infection including: tuberculosis, hepatitis B (known positive hepatitis B surface antigen (HBsAg) result) and/or, hepatitis C. Patients with a past or resolved hepatitis B infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA (indicating no current infection). * Known positive test for human immunodeficiency virus (positive HIV 1/2 antibodies) or known medical history of acquired immunodeficiency syndrome (AIDS) * Adequate bone marrow function measured within 28 days prior to administration of study as defined per protocol. * Adequate rental function as defined per protocol. * Adequate hepatic function as defined per protocol * Women of childbearing potential (WOCBP) patients or male patients who are sexually active with WOCBP and female partners of male participants must agree to follow instructions of "highly effective methods of contraception) per protocol for duration of treatment with study drug(s) plus the specified washout period. * Male participants must be willing to refrain from sperm donation during the study and for at least 180 days after the last dose of durvalumab combination therapy, 90 days after the last dose of durvalumab or olaparib monotherapy. Exclusion Criteria: * Participants with previous brain metastases are eligible provided that they are treated, are asymptomatic, and have stable disease at the screening tumor assessment. A ≥ 2 week disease stable interval as confirmed by MRI or CT brain w/ contrast (Table 7.4-2) is required after treatment of brain metastases before initiation of thoracic XRT. In addition, subjects must have been either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent). * Participants who have received prior thoracic XRT are excluded. * Participants with Carcinomatous meningitis * Pregnant or breastfeeding women * Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, Wegener syndrome and hypophysitis or uveitis. Patients with an autoimmune paraneoplastic syndrome requiring concurrent immunosuppressive treatment are excluded. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll * Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study treatment (excluding thoracic radiotherapy). Some exceptions apply. * Prior CPI therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways). Exception: CPI use with first line chemotherapy that is stopped prior to trial enrollment. * Participants who have received any previous treatment with a Poly ADP Ribose Polymerase (PARP) inhibitor, including olaparib * Interstitial lung disease (ILD): Any evidence of current ILD or pneumonitis or a prior history of ILD or pneumonitis requiring oral or IV glucocorticoids. * Previous malignancies unless a complete control (no evidence of disease) was achieved ≥ 2 years prior to study entry AND no additional therapy is required during the study period (EXCEPT: adequately treated non-melanoma skin cancer, curatively treated in situ cancer and stage 1, grade 1 endometrial cancer). * Participants with a known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results. * Major surgery or significant traumatic injury that is not recovered at least 14 days before the initiation of thoracic radiation therapy * All toxicities attributed to prior anti-cancer therapy must have been resolved to Grade 1 (NCI CTCAE Version 5.0) or baseline before administration of study drug(s). Some exceptions apply. * Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients. * Patients with known contraindications to radiotherapy, including inherited syndromes associated with hypersensitivity to ionizing radiation (e.g., Ataxia-Telangiectasia, Nijmegen Breakage Syndrome). * History of allergy or hypersensitivity to any of the study drugs or study drug components

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

More trials for these conditions

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