AzTrials
AzTrials

Lung CancerPhase 2NCT05245994

An Open Label, Multicenter Phase 2 Study of Durvalumab (MEDI4736) + Olaparib as Maintenance Therapy in Chinese

A Phase 2 study testing Durvalumab, etoposide, and cisplatin/carboplatin followed by durvalumab and olaparib in people with Lung Cancer and Small Cell Lung Cancer, run by Li Zhang, MD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The purpose of this study was to evaluate the efficacy and safety of combining durvalumab with EP followed by durvalumab + olaparib maintenance therapy as first-line treatment in patients with extensive-disease small-cell lung cancer (SCLC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Small Cell Lung Cancer, Durvalumab
What is being tested?
Durvalumab, etoposide, and cisplatin/carboplatin followed by durvalumab and olaparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
21 Aug 2021to Nov 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female ≥18 years at the time of screening.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
  • Histologically or cytologically documented extensive disease (American Joint Committee on Cancer Stage (7th edition) IV SCLC [T any, N any, M1 a/b]), or T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.
  • Brain metastases; must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment. Patients with suspected brain metastases at screening should have a CT/MRI of the brain prior to study entry.
  • Provision of an archived tumor tissue block (or at least 15 newly cut unstained slides) where such samples exist.
Show all 25Show fewer
  • Patients must be considered suitable to receive a platinum based chemotherapy regimen as 1st line treatment for the ED-SCLC. Chemotherapy must contain either cisplatin or carboplatin in combination with etoposide.
  • Life expectancy ≥16 weeks at Day 1.
  • World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 at enrollment. PS2 patients are permitted to receive first-line treatment, and PS score should be reassessed after first-line treatment. Then patients who are assessed as PS2 at the completion of chemotherapy+durvalumab will be excluded.
  • Body weight >30 kg.
  • At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes which must have a short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines.
  • No prior exposure to immune-mediated therapy including, but not limited to, other PARP inhibitor, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.
  • Adequate organ and marrow function which is measured within 28 days prior to administration of study treatment as defined below:
  • Hemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days Absolute neutrophil count ≥1.5 × 109/L (use of granulocyte colony-stimulating factor is not permitted at screening).
  • Platelet count ≥100 × 109/L. Serum bilirubin ≤1.5 × the upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome, who will be allowed in consultation with their physicians.
  • In patients without hepatic metastasis: ALT and AST ≤2.5 × ULN. In patients with hepatic metastases, ALT and AST ≤5 × ULN.
  • Measured or calculated creatinine clearance: >60mL/min for patients on cisplatin and >51mL/min for patients on carboplatin, as determined by Cockcroft-Gault (using actual body weight) or based on a 24 hour urine test:
  • Males:
  • Creatinine CL (mL/min) = [Weight (kg) × (140 - Age)] / [72 × Serum creatinine (mg/dL)]
  • Females:
  • Creatinine CL (mL/min) = {[Weight (kg) × (140 - Age)] / [72 × Serum creatinine (mg/dL)]}0.85
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  • Women <50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
  • Male patients must use a condom during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception

Who cannot join

  • Previous IP assignment in the present study.
  • Concurrent enrollment in another clinical study, unless it is an observational (non interventional) clinical study or during the follow up period of an interventional study.
  • Participation in another clinical study with an IP during the last 4 weeks.
  • Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
  • Medical contraindication to etoposide platinum (carboplatin or cisplatin) based chemotherapy.
  • Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy. Radiation therapy outside of the chest for palliative care (ie, bone metastasis) is allowed but must be completed before first dose of the study medication.
Show all 33Show fewer
  • Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer related conditions (eg, hormone replacement therapy) is acceptable.
  • Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
  • History of allogeneic organ transplantation.
  • Has a paraneoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis with the exception of diverticulosis, systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, and uveitis, etc]). The following are exceptions to this criterion:
  • Patients with vitiligo or alopecia Patients with hypothyroidism (eg, following Hashimoto syndrome) and stable on hormone replacement Any chronic skin condition that does not require systemic therapy Patients without active disease in the last 5 years may be included but only after consultation with the investigator Patients with celiac disease controlled by diet alone
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, interstitial lung disease, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
  • History of another primary malignancy except for Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease Adequately treated carcinoma in situ without evidence of disease
  • History of leptomeningeal carcinomatosis.
  • History of active primary immunodeficiency.
  • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive HBV surface antigen [HbsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HbsAg) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or olaparib. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids or local steroid injections (eg, intra articular injection).
  • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent.
  • Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication). Premedication with steroids for chemotherapy is acceptable.
  • Receipt of live, attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
  • Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from Screening to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of durvalumab + olaparib combination therapy.
  • Known allergy or hypersensitivity to durvalumab, olaparib, etoposide, carboplatin, cisplatin, or any of their excipients
  • Prior randomization or treatment in a previous durvalumab and/or olaparib clinical study regardless of treatment arm assignment.
  • *Other malignancy unless curatively treated with no evidence of disease for ≥5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma.
  • 23. Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.
  • 24) Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
  • 25) Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
  • 26) Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
  • 27) Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort ) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting Olaprrib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
  • 28) Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
  • 29) Breast feeding women. 30) Patients with a known hypersensitivity to the combination/comparator agent. 31) As judged by the investigator, any evidence of which in the investigator's opinion makes it undesirable for the patient to participate in the trial.

Trial locations and contacts

1 site in 1 country.

LI ZHANG contact

020-87343533

zhangli@sysucc.org.cn

YAN HUANG contact

020-87342331

huangyan@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Yan Huang, 020-87342331, huangyan@sysucc.org.cn

    Xianling Liu

    Recruiting

Other trials in China

About this study

Official title: An Open Label, Multicenter Phase 2 Study of Durvalumab (MEDI4736) + Olaparib as Maintenance Therapy in Patients With Extensive Stage Small-Cell Lung Cancer

The purpose of this study was to evaluate the efficacy and safety of combining durvalumab with EP followed by durvalumab + olaparib maintenance therapy as first-line treatment in patients with extensive-disease small-cell lung cancer (SCLC).

Read the detailed description

This study is planned to enroll approximately 60 eligible patients in China. Patients who fulfill all the inclusion criteria and none of the exclusion criteria will receive 4 cycles of EP with durvalumab, then durvalumab + olaparib will be administered post-chemotherapy until confirmed progressive disease (PD).Tumor assessments will be performed at Screening as baseline with follow-up at Week 6 ±1 week from the date of the first cycle treatment, at Week 12 ±1 week from the date of the first cycle treatment, and then every 8 weeks ±1 week until confirmed objective disease progression. The primary endpoint is APF12, which is defined as the Proportion of patients alive and progression free at 12 months from the first date of the first-line treatment.

Being tested
Durvalumab, etoposide, and cisplatin/carboplatin followed by durvalumab and olaparib
Keywords
ES-SCLC, Durvalumab, Olaparib
Medical subject headings
Lung Neoplasms, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Durvalumab, etoposide, and cisplatin/carboplatin followed by durvalumab and olaparibDrug

    Durvalumab 1500 mg intravenous infusion, started to be used simultaneously with chemotherapy at week 0 and continued after chemotherapy. Starting from week 0, the dose of etoposide + carboplatin or cisplatin in the study will not exceed the dose for specific indications in the product instructions (etoposide [80 to 100mg/m2] via intravenous infusion and carboplatin [ The area under the curve (AUC) is 5-6] by intravenous infusion or cisplatin [75-80 mg/m2] by intravenous infusion), using up to 4 cycles. The choice of platinum drugs is at the discretion of the investigator. The initial dose of olaparib is 300mg twice daily. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. The tablets should be swallowed whole and not chewed, crushed, dissolved or divided. Olaparib tablets can be taken with or without food.

Study groups in NCT05245994
Study groupRoleWhat they receive
Durvalumab, etoposide, and cisplatin/carboplatin followed by durvalumab and olaparibExperimentalNot described
Receives: Drug: Durvalumab, etoposide, and cisplatin/carboplatin followed by durvalumab and olaparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. APF12-Alive and Progression Free

    A proportion of patients alive and progression free at 12 months from the first date of first-line treatment

    Measured: 1 year

Secondary outcomes (4)

  1. PFS0-Progression Free Survival 0

    The time from the first date of first-line treatment until the date of objective disease progression or death.

    Measured: 2 years

  2. PFS-Progression Free Survival

    The time from the first date of maintenance treatment until the date of objective disease progression or death.

    Measured: 2 years

  3. OS-Overall Survival

    The time from the start of first-line treatment to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.

    Measured: 2 years

  4. ORR-Objective Response Rate

    Objective response rate after the given treatment in patients accoeding to the evaluation criteria of RECIST1.1.

    Objective response rate after the given treatment according to the evaluation criteria of RECIST1.1

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2022
  2. Study start21 Aug 2021
  3. Primary completionMay 2023 (estimated)
  4. Study completionNov 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05245994
Sponsor's protocol ID
ESR-20-20659
Status last verified
Jan 2022
First submitted
23 Jan 2022
Last updated
18 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhao Y, Wang Q, Xiao B, Jia J, Liu X, Ma S, Liu H, Zhou T, Yang Y, Fang W, Zhang L, Huang Y. DNA hypomethylation identifying clinical benefit subgroup of small-cell lung cancer: multi-omics analysis of a phase II trial with durvalumab plus olaparib as maintenance therapy. J Immunother Cancer. 2026 Aug 14;14(8):e015066. doi: 10.1136/jitc-2026-015066.

    PubMed 42601174

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab, etoposide, and cisplatin/carboplatin followed by durvalumab and olaparib in people with Lung Cancer and Small Cell Lung Cancer, run by Li Zhang, MD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact LI ZHANG (020-87343533, zhangli@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

APF12-Alive and Progression Free (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05245994, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in