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Extensive-stage Small Cell Lung CancerPhase 2NCT04562337

SHR-1316 Combined With Chemotherapy and Chest Radiotherapy in ES-SCLC

A Phase 2 study testing SHR1316, Carboplatin and Etoposide in people with Extensive-stage Small Cell Lung Cancer, run by Shandong Cancer Hospital and Institute 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 The sponsor has not verified this record for over two years, so it may be out of date.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 study is a one arm, open, single center phase II study. The main purpose of this study was to evaluate the tolerance and preliminary efficacy of SHR1316 combined with chest radiotherapy after induction therapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Extensive-stage Small Cell Lung Cancer
What is being tested?
SHR1316, Carboplatin and Etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteChina
Study dates
1 Oct 2020to Oct 2024
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

  • Confirmed diagnosis of Extensive small cell lung cancer
  • Eastern Cooperative Oncology Group performance status (PS) of 0 to 1
  • 18 to 75 years old
  • The function of vital organs meets the following requirements. WBC ≥ 3.0 × 10^9/L, ANC≥1.5×10^9/L, PLT≥100×10^9/L, Hb≥9g/dL, ALT and AST ≤2.5 times ULN, TBIL ≤1.5 x ULN, CREA ≤1.5 times ULN or CCr≥50mL/min. INR≤1.5 x ULN, APTT ≤1.5 x ULN
  • have not received first-line systemic therapy or immunosuppressive therapy for es-sclc
  • The estimated survival period is more than 8 weeks
  • With measurable lesion defined by the RECIST v1.1: Previously irradiated lesions may only be considered as measurable disease if disease progression has been unequivocally documented at that site since radiation and the previously irradiated lesion is not the only site of disease;
  • Signed written informed consent prior to study entry

Who cannot join

  • Active or untreated CNS metastases
  • Leptomeningeal diseases
  • Uncontrolled or symptomatic hypercalcemia
  • Active, known or suspected autoimmune diseases
  • have received any T cell co stimulation or immune checkpoint therapy
  • Corticosteroids (> 10 mg / day prednisone or equivalent) or other immunosuppressants were used within 14 days before the first dose of study drug.
Show all 11Show fewer
  • Subjects had active infections.
  • Failing to properly control the clinical symptoms or disease of the heart
  • Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation
  • Known to be allergic to the study drug or excipients, known to have a serious allergic reaction to any kind of monoclonal antibody; have a history of hypersensitivity to cisplatin or etoposide
  • According to the researcher's judgment, there are other factors that may lead to the termination of the study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shandong Cancer Hospital and Institute

    Jinan, Shandong

Other trials in China

About this study

Official title: SHR-1316 Plus Chemotherapy and Sequential Thoracic Radiotherapy as First-line Therapy for Extensive-stage Small-Cell Lung Cancer (ES-SCLC): a Phase II Trial

This study is a one arm, open, single center phase II study. The main purpose of this study was to evaluate the tolerance and preliminary efficacy of SHR1316 combined with chest radiotherapy after induction therapy.

Read the detailed description

This is a single-arm, single-center phase II study. Eligible subjects will receive the following treatment regimens: 4~6 cycles of SHR1316 combined with EP/EC (etoposide, 100mg/m2, D1-3, q3w and cisplatin, 75mg/m², D1, q3w or carboplatin, AUC=5, D1, q3w). Patients with response sequentially received adebrelimab combined with chest radiotherapy based on investigator decision. Patients then the maintenance therapy with adebrelimab until disease progression or intolerable AEs.

Being tested
SHR1316, Carboplatin, Etoposide, Radiation therapy, Cisplatin
Keywords
SHR1316, Chemotherapy, 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.

  • SHR1316Drug

    Also called Adebrelimab

    Anti-PD-L1 antibody

  • CarboplatinDrug

    Carboplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).

  • EtoposideDrug

    Etoposide intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).

  • Radiation therapyRadiation

    Thoracic radiation therapy ,TRT

  • CisplatinDrug

    Cisplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).

Study groups in NCT04562337
Study groupRoleWhat they receive
SHR1316+Chemotherapy +RadiotherapyExperimentalPaiticipant receive SHR-1316 、Chemotherapy and Radiotherapy
Receives: Drug: SHR1316; Drug: Carboplatin; Drug: Etoposide; Radiation: Radiation therapy; Drug: Cisplatin

What is being measured

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

  1. overall survival （OS）

    Measured: Up to approximately 36 months

Secondary outcomes (7)

  1. progression-free survival (PFS)

    Measured: Up to approximately 36 months

  2. Objective Response Rate (ORR)

    Measured: Up to approximately 36 months

  3. disease control rate (DCR)

    Measured: Up to approximately 36 months

  4. Duration of Response (DOR)

    Measured: Up to approximately 36 months

  5. Adverse events

    Safety, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) per CTCAE 5.0 criteria

    Measured: Up to approximately 36 months

  6. 6- and 12-month PFS rates

    Percentage of Participants Alive and Without PD, as Assessed by the Investigator Using RECIST v1.1, at 6 Months and 12 Months

    Measured: 6 Months and 12 Months

  7. 1- and 2-year OS rates

    Percentage of Participants Alive at 1 Year and 2 Years

    Measured: 1 Year and 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 posted24 Sep 2020
  2. Study start1 Oct 2020
  3. Primary completionOct 2024 (estimated)
  4. Study completionOct 2024 (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
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04562337
Sponsor's protocol ID
ES-SCLC-1st-IIT-SHR1316-CRT
Status last verified
Jun 2024
First submitted
28 Aug 2020
Last updated
3 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen D, Zou B, Li B, Gao A, Huang W, Shao Q, Meng X, Zhang P, Tang X, Hu X, Zhang Y, Guo J, Zhao C, Yuan J, Li Q, Zhu C, Yu J, Wang L. Adebrelimab plus chemotherapy and sequential thoracic radiotherapy as first-line therapy for extensive-stage small-cell lung cancer (ES-SCLC): a phase II trial. EClinicalMedicine. 2024 Aug 21;75:102795. doi: 10.1016/j.eclinm.2024.102795. eCollection 2024 Sep.

    PubMed 39252865

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR1316, Carboplatin and Etoposide in people with Extensive-stage Small Cell Lung Cancer, run by Shandong Cancer Hospital and Institute 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 8 inclusion and 11 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 3 Jul 2024. 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?

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?

overall survival （OS） (time frame: Up to approximately 36 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 NCT04562337, 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 3 Jul 2024.

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