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Small-cell Lung CancerPhase 2NCT04951115

A Trial With Chemotherapy, Immunotherapy, and Radiotherapy for Patients With Newly Diagnosed Stage IV Small Cell Lung Cancer

A Phase 2 study testing Carboplatin, Cisplatin and Etoposide in people with Small-cell Lung Cancer, run by Weill Medical College of Cornell University at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is for subjects with untreated Stage IV small cell lung cancer. Subjects will be given radiation therapy for five days, followed by standard of care chemo-immunotherapy (etoposide + carboplatin or cisplatin + durvalumab) for 4 cycles. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small-cell Lung Cancer
What is being tested?
Carboplatin, Cisplatin and Etoposide
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
3 sitesUnited States
Study dates
12 Jul 2021to 17 Jan 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Adults ≥ 18 years old
  • Written informed consent from subject or from Health Care Proxy prior to performing any protocol-related procedures, including screening evaluations.
  • Pathological diagnosis of SCLC from biopsy (core biopsy or fine needle aspiration); mixed-histology (NSCLC and SCLC) allowed
  • ES-SCLC (American Joint Committee on Cancer, 8th edition, stage IV [T any, N any, M1a or M1b], or T3-4 due to multiple lung nodules that are too extensive or tumor or nodal volume that is too large to be encompassed in a tolerable radiation plan)
  • Brain metastases allowed, but must be asymptomatic without the need for systemic steroids at doses more than 10 mg/day of prednisone or its equivalent, or treated with Whole Brain Radiation Therapy (WBRT) or Stereotactic Radiosurgery (SRS)
  • Body weight > 30kg
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  • ECOG Performance Status (PS) 0-1 at enrollment. ECOG PS 2 allowed if PS decline considered by treating study investigator to be secondary to SCLC
  • At least 1 lesion 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 CT, PET-CT, or MRI and that is suitable for accurate repeated measurements as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.
  • No prior exposure to IO therapy including, but not limited to, anti-CTLA-4, anti-PD-1, antiPD-L1, and anti-PD-L2 antibodies
  • No prior radiation therapy in the past 3 years prior to study enrollment. Radiation treatment of brain metastases from small cell lung cancer will be permitted, as per inclusion criteria 5 above. Other specific radiotherapy treatments occurring within the past 3 years, such as electron beam therapy for skin cancers, pterygium irradiation with Sr-90 or SRS for non-malignant disease, or prior I-131 for hyperthyroidism, may not be an absolute contraindication, and will be considered on a case by case basis.
  • Life expectancy of at least 12 weeks from the start of therapy
  • Adequate baseline organ functions as defined below
  • Hemoglobin ≥8.0 g/dL.
  • Absolute neutrophil count ≥1.5 × 103/uL (use of granulocyte colony-stimulating factor is not permitted at screening).
  • Platelet count ≥75 × 103/uL.
  • Serum bilirubin ≤1.5 × the ULN. This will not apply to patients with confirmed Gilbert's syndrome, who will be allowed in consultation with their physician.
  • In patients without hepatic metastasis: ALT and AST ≤2.5 × ULN; for patients with hepatic metastases, ALT and AST ≤5 × ULN.
  • Measured or calculated creatinine clearance: >60 mL/min for patients on cisplatin and >45 mL/min for patients on carboplatin, as determined by Cockcroft-Gault (using actual body weight).
  • Males: Creatinine clearance (mL/min) = [Weight (kg) × (140 - Age)]/[72 × serum creatinine (mg/dL)]
  • Females: Creatinine clearance (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 amenorrhoeic 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 amenorrhoeic 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).

Who cannot join

  • Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
  • Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
  • Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
  • Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study.
  • Participation in another clinical study with a therapeutic investigational product during the last 4 weeks.
  • Contraindications to platinum-based chemotherapy
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  • Contraindications to radiation therapy
  • Prior radiation therapy to same site as proposed SBRT site
  • Cannot tolerate radiation treatment position or immobilization
  • Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable, as is use of bisphosphonate or RANKL inhibitor therapy for prevention of skeletal-related events from bone metastases.
  • History of another primary malignancy except for:
  • Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of the investigational product and of low potential risk for recurrence.
  • Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease.
  • Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ).
  • History Limited-Stage SCLC treated with concurrent chemo-radiation
  • History of allogenic organ transplantation.
  • Major surgical procedure (as defined by the investigator) within 28 days prior to Cycle 1 Day1 of systemic therapy and SBRT. Local surgery of isolated lesions for palliative intent is acceptable.
  • Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents)
  • Documented, active, and uncontrolled autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, systemic lupus erythematosus, sarcoidosis syndrome, 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 (e.g., following Hashimoto syndrome) stable on hormone replacement
  • Any chronic skin condition that does not require systemic therapy.
  • Patients with celiac disease controlled by diet alone.
  • Patients without active disease in the last 5 years may be included but only after consultation with the medical monitor and with appropriate subspecialty consultation (e.g. with endocrinology, gastroenterology, rheumatology, etc.)
  • Patients whose autoimmune or inflammatory disorder is controlled with medication may be included but only after consultation with the medical monitor and with appropriate subspecialty consultation (e.g. with endocrinology, gastroenterology, rheumatology, etc.)
  • Uncontrolled intercurrent illness, including but not limited to, uncontrolled ongoing or active infection, interstitial lung disease, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled 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 adverse events, or compromise the ability of the patient to give written informed consent.
  • Active infection, including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), HBV (known positive HBV surface antigen result), HCV, or HIV (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of HBV core antibody and absence of HBV surface antigen) are eligible, as are patients with HBV infection controlled by antiviral medication (defined as undetectable viral load). Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., 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 (e.g., CT scan premedication). Premedication with steroids for chemotherapy is acceptable.
  • History of active primary immunodeficiency.
  • Receipt of live, attenuated vaccine within 30 days prior to the first dose of durvalumab
  • Female patients who are pregnant or breast-feeding 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.
  • Known allergy or hypersensitivity to durvalumab, etoposide, carboplatin, cisplatin, or any of their excipients.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • New York-Presbyterian Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

  • New York-Presbyterian Queens

    Flushing, New York, 11355

  • Weill Cornell Medicine

    New York, New York, 10065

Other trials in United States

About this study

Official title: Phase II Trial of Platinum-Etoposide Chemotherapy and Durvalumab (MEDI4736) With Sub-Ablative SBRT in Patients With Newly Diagnosed Stage IV Small Cell Lung Cancer

This study is for subjects with untreated Stage IV small cell lung cancer. Subjects will be given radiation therapy for five days, followed by standard of care chemo-immunotherapy (etoposide + carboplatin or cisplatin + durvalumab) for 4 cycles. Subjects may continue to receive durvalumab after 4 cycles have been completed until disease progression.

Read the detailed description

This is a non-randomized, open-label, single-arm pilot phase II study of non-ablative stereotactic body radiotherapy (SBRT) in combination with standard-of-care chemo-immunotherapy in patients with untreated, extensive-stage (Stage IV) small cell lung cancer. Subjects will be treated with etoposide plus platinum (carboplatin or cisplatin) chemotherapy together with the PD-L1 checkpoint inhibitor durvalumab, which is a standard of care in this disease setting. Subjects will also receive a total of 6 Gy of radiotherapy X 5 fractions targeting multiple sites of intrathoracic disease when feasible and starting on the first day of the first cycle of chemo-immunotherapy; no further radiation will be planned after this. The hypothesis of this study is that the addition of sub-ablative doses of radiation to combination chemotherapy and immunotherapy will be safe and feasible and result in improved outcomes for patients with treatment-naive, extensive-stage small cell lung cancer.

Being tested
Carboplatin, Cisplatin, Etoposide, Durvalumab, Stereotactic Body Radiotherapy
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • CarboplatinDrug

    AUC = 5-6 mg/mL per min on Day 1 of each 21-day cycle, for 4 cycles

  • CisplatinDrug

    75-80 mg/m2 on Day 1 of each 21-day cycle, for 4 cycles

  • EtoposideDrug

    80-100 mg/m2 on Day 1, Day 2, and Day 3 of each 21-day cycle, for 4 cycles

  • DurvalumabDrug

    1500 mg on Day 1 of each 21-day cycle, for 4 cycles. Following this, 1500 mg once every 4 weeks until disease progression

  • Stereotactic Body RadiotherapyRadiation

    6 Gy of radiotherapy targeting multiple sites of intrathoracic disease on Days 1-5 of cycle 1.

Study groups in NCT04951115
Study groupRoleWhat they receive
Radiation + Chemo-ImmunotherapyExperimentalNot described
Receives: Drug: Carboplatin; Drug: Cisplatin; Drug: Etoposide; Drug: Durvalumab; Radiation: Stereotactic Body Radiotherapy

What is being measured

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

  1. Number of Toxicities Grade 3 or Above Related to Therapy

    Measured by the number of adverse of events that are deemed definitely or probably related to the treatments given while receiving study treatment

    Measured: Up to 29 months

  2. Efficacy of Multi-site, Non-ablative Radiation to Standard Systemic Therapy for Patients With Extensive-stage Small Cell Lung, as Measured by a Change in Disease Response

    Progression free survival at 12 months

    Measured: Up to 12 months

Secondary outcomes (3)

  1. Objective Response Rate, Determined by Disease Response Rate Defined by the RECIST 1.1 Criteria

    Measured: Through study completion (an average of 2 years)

  2. Overall Survival, Defined as the Time From First Study Treatment to the Time of Death From Any Cause

    To determine the percentage of subjects that have achieved survival at the 12 month timepoint

    Measured: Up to 12 months

  3. Pattern of Disease Progression, Defined by the Progression in Radiated Lesions vs. Non-radiated Lesions and the Rates of New Lesions as Determined by RECIST 1.1

    Determined by the number of subjects that experienced disease progression in radiated vs. non-radiated lesions and if there were any new lesions

    Measured: From baseline through progression of disease (approximately 12 months)

Timeline

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

  1. First posted6 Jul 2021
  2. Study start12 Jul 2021
  3. Primary completion17 Jan 2024
  4. Study completion17 Jan 2024

Why it stopped: The study was terminated early due to low accrual.

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04951115
Sponsor's protocol ID
20-08022492
Status last verified
Nov 2024
First submitted
22 Jun 2021
Last updated
26 Nov 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Cisplatin and Etoposide in people with Small-cell Lung Cancer, run by Weill Medical College of Cornell University at 3 sites in United States.

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 23 inclusion and 35 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: stopped early, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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?

Yes. Results are posted in the registry (first posted 26 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Toxicities Grade 3 or Above Related to Therapy (time frame: Up to 29 months). The study lists 2 primary outcomes in all. 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 NCT04951115.

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 26 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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