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Small-cell Lung CancerPhase 2NCT04696939

Combined Atezolizumab and Chemotherapy (Carboplatin Plus Etoposide) in Neoadjuvant Treating Limited-Stage Small Cell Lung Cancer Patients

A Phase 2 study testing Atezolizumab, Carboplatin and Etoposide in people with Small-cell Lung Cancer and Neoadjuvant Therapy, run by Shanghai Pulmonary Hospital, Shanghai, China 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

This Phase II study was designed to evaluate the safety and efficacy of Atezolizumab in combination with Chemotherapy compared with treatment with Chemotherapy alone in previously untreated Limited-Stage Small Cell Lung Cancer patients. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Small-cell Lung Cancer, Neoadjuvant Therapy
What is being tested?
Atezolizumab, Carboplatin and Etoposide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
Jan 2021to Oct 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be volunteered to participate in the clinical trial. Patients must sign the informed Consent form (ICF) and be willing to follow and able to complete all test procedures.
  • Histologically or cytologically confirmed stage IIb-IIIb SCLC.
  • Patients with good physical condition and good organ function.
  • Previously untreated patients.
  • Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Patients can tolerate chemotherapy, immunotherapy, and surgery.

Who cannot join

  • Unclear diagnosis of SCLC.
  • Contraindicated chemotherapy, immunotherapy, and surgery.
  • Undergoing other active malignancies within 5 years or at the same time.Patients with localized curable tumors, such as basal cell carcinoma, squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ, will not be excluded.
  • Positive test result for human immunodeficiency virus (HIV).
  • Positive test result for active tuberculosis.
  • Pregnant or lactating women
  • A history of psychotropic substance abuse, drug abuse, or alcoholism.
  • Other factors assessed by the sponsors.

Trial locations and contacts

1 site in 1 country.

Yayi He, Doctor contact

+86-21-65115006 ext. 3056

2250601@qq.com

China1 site

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

    Yayi He, Doctor, +86-21-65115006, 2250601@qq.com

Other trials in China

About this study

Official title: Clinical Study of Programmed Cell Death Ligand-1(PD-L1) Antibody (Atezolizumab) Plus Chemotherapy (Carboplatin Plus Etoposide) for Previously Untreated Small Cell Lung Cancer

This Phase II study was designed to evaluate the safety and efficacy of Atezolizumab in combination with Chemotherapy compared with treatment with Chemotherapy alone in previously untreated Limited-Stage Small Cell Lung Cancer patients.

Read the detailed description

This Phase II study was designed to evaluate the safety and efficacy of Atezolizumab in combination with Chemotherapy (Carboplatin plus Etoposide) compared with treatment with Chemotherapy (Carboplatin plus Etoposide) alone in previously untreated Limited-Stage Small Cell Lung Cancer patients. Participants will be divided in a 1:1 ratio to receive either Atezolizumab + Carboplatin + Etoposide or Carboplatin + Etoposide followed by radical surgery.

Keywords
Limited-Stage Small Cell Lung Cancer, Atezolizumab, Immunotherapy, Carboplatin, Etoposide
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.

  • AtezolizumabDrug

    Atezolizumab intravenous infusion was administered at a dose of 1200mg on Day 1 of each 21-day cycle.

  • CarboplatinDrug

    Carboplatin intravenous infusion was administered at a dose of 75mg/m^2 on Day 1 of each 21-day cycle.

  • EtoposideDrug

    Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Day 1 of every 3-day cycle.

Study groups in NCT04696939
Study groupRoleWhat they receive
Atezolizumab + Carboplatin +Etoposide +surgeryExperimentalNeoadjuvant therapy: Atezolizumab, 1200 milligrams(mg) on Day 1 of every 21-day cycle, 2 cycles; Carboplatin, 75 mg per square meter(mg/m^2) on Day 1 of every 21-day cycle, 2 cycles; Etoposide, 100 mg/m^2 on Day 1 of every 3-day cycle, 2 cycles. Surgery: patients will receive surgery.
Receives: Drug: Atezolizumab; Drug: Carboplatin; Drug: Etoposide
Carboplatin +Etoposide +surgeryActive comparatorNeoadjuvant therapy: Carboplatin, 75 mg/m^2 on Day 1 of every 21-day cycle, 2 cycles; Etoposide, 100 mg/m^2 on Day 1 of every 3-day cycle, 2 cycles. Surgery: patients will receive surgery.
Receives: Drug: Carboplatin; Drug: Etoposide

What is being measured

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

  1. Disease free survival（DFS）

    To assess disease free survival（DFS）after surgery.

    Measured: 12 months

Secondary outcomes (6)

  1. Disease control rate (DCR)

    To assess disease control rate (DCR) after treatment.

    Measured: 3 months

  2. Overall survival (OS)

    To estimate overall survival (OS) of patients with ES-SCLC.

    Measured: 24 months

  3. Objective response rate (ORR)

    To evaluate objective response rate (ORR)after treatment.

    Measured: 3 months

  4. Duration of response (DOR)

    To evaluate duration of response (DOR) after treatment.

    Measured: 3 months

  5. Major pathological response (MPR)

    To evaluate major pathological response (MPR) after treatment.

    Measured: 3 months

  6. Complete pathological response (CPR）

    To evaluate complete pathological response (CPR）after treatment.

    Measured: 3 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 Jan 2021
  2. Study startJan 2021 (estimated)
  3. Primary completionAug 2022 (estimated)
  4. Study completionOct 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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04696939
Sponsor's protocol ID
2020LY032
Status last verified
Jan 2021
First submitted
4 Jan 2021
Last updated
6 Jan 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Paz-Ares L, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Ozguroglu M, Ji JH, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Kazarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Shire N, Jiang H, Goldman JW; CASPIAN investigators. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet. 2019 Nov 23;394(10212):1929-1939. doi: 10.1016/S0140-6736(19)32222-6. Epub 2019 Oct 4.

    PubMed 31590988

  • Horn L, Mansfield AS, Szczesna A, Havel L, Krzakowski M, Hochmair MJ, Huemer F, Losonczy G, Johnson ML, Nishio M, Reck M, Mok T, Lam S, Shames DS, Liu J, Ding B, Lopez-Chavez A, Kabbinavar F, Lin W, Sandler A, Liu SV; IMpower133 Study Group. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018 Dec 6;379(23):2220-2229. doi: 10.1056/NEJMoa1809064. Epub 2018 Sep 25.

    PubMed 30280641

  • Yang CJ, Chan DY, Shah SA, Yerokun BA, Wang XF, D'Amico TA, Berry MF, Harpole DH Jr. Long-term Survival After Surgery Compared With Concurrent Chemoradiation for Node-negative Small Cell Lung Cancer. Ann Surg. 2018 Dec;268(6):1105-1112. doi: 10.1097/SLA.0000000000002287.

    PubMed 28475559

  • Yang CJ, Chan DY, Speicher PJ, Gulack BC, Tong BC, Hartwig MG, Kelsey CR, D'Amico TA, Berry MF, Harpole DH. Surgery Versus Optimal Medical Management for N1 Small Cell Lung Cancer. Ann Thorac Surg. 2017 Jun;103(6):1767-1772. doi: 10.1016/j.athoracsur.2017.01.043. Epub 2017 Apr 25.

    PubMed 28385378

  • Faivre-Finn C, Snee M, Ashcroft L, Appel W, Barlesi F, Bhatnagar A, Bezjak A, Cardenal F, Fournel P, Harden S, Le Pechoux C, McMenemin R, Mohammed N, O'Brien M, Pantarotto J, Surmont V, Van Meerbeeck JP, Woll PJ, Lorigan P, Blackhall F; CONVERT Study Team. Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial. Lancet Oncol. 2017 Aug;18(8):1116-1125. doi: 10.1016/S1470-2045(17)30318-2. Epub 2017 Jun 20.

    PubMed 28642008

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab, Carboplatin and Etoposide in people with Small-cell Lung Cancer and Neoadjuvant Therapy, run by Shanghai Pulmonary Hospital, Shanghai, China 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 6 inclusion and 8 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 6 Jan 2021. 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 Yayi He, Doctor (+86-21-65115006 ext. 3056, 2250601@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease free survival（DFS） (time frame: 12 months). 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 NCT04696939, which also lists 5 linked publications.

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 6 Jan 2021.

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