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Extensive-stage Small Cell Lung CancerPhase 2NCT04636762

A Study of Concurrent Chemoradiation With Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)

A Phase 2 study testing Radiation Therapy in people with Extensive-stage Small Cell Lung Cancer, run by Second Xiangya Hospital of Central South University at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Etoposide-cisplatin/ -carboplatin in combination with PD-L1 inhibitor for 4 cycles followed by maintenance therapy with PD-L1 inhibitor is currently the world-wide first-line treatment for extensive-stage small cell lung cancer. 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?
Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesChina
Study dates
1 Jun 2020to 1 May 2022
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

  • 1.Histologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system) 2.Must sign a written informed consent form prior to any study specific procedures 3. No prior treatment for ES-SCLC 4.Measurable disease, as defined by RECIST v1.1 5.Can tolerate radiotherapy, no contraindication of radiotherapy 6.Weight≥40kg 7.Life expectancy>12 weeks 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1. 9.Systemic immunosuppressive doses of corticosteroids (prednisone>10 mg/d or equivalent) was discontinued at least 2 weeks before registration for protocol therapy.
  • 10. Be willing to provide 20 tissue sections(4-6 micron thickness) from a newly obtained core or excisional biopsy of a tumor lesion, for biomarker exploration; newly-obtained is defined as a specimen obtained within 3 months before initiation of treatment on day 1; newly-obtained samples must be core needle biopsy, excision, or incision 11.Must have adequate organ function defined by the following laboratory results:
  • Absolute neutrophil count (ANC) ≥ 1.5×109/L, Platelets≥ 100×109/L, Hemoglobin≥90g/L
  • Serum creatinine ≤ 1.5 upper limit of normal (ULN) OR calculated creatinine clearance≥60 mL/min(using Cock-Gault formula)
  • Total bilirubin ≤1.5 ULN or for total bilirubin level ≥1.5 ULN, direct bilirubin is within normal limits; AST (SGOT) and ALT (SGPT)≤2.5 ULN.
  • The thyroid-stimulating hormone (TSH) is within normal range. Note: If the Baseline TSH is not within the normal range, and T3 and T4 are within the normal range, the subject may still meet the inclusion criteria.
  • International normalized ratio(INR) or prothrombin time(PT), activated partial thromboplastin time (APTT)≤1.5 ULN, exception: In subjects receiving anticoagulant therapy, as long as PT or APTT is within the recommended use of anticoagulants
  • Baseline ECG showed no prolonged PR interval or atrioventricular block. 12.Women of child-bearing potential should agree that contraception (such as intrauterine devices(LUD), birth control pills or condoms) must be used during the course of the study through 6 months after the last dose of study medication, and women of childbearing potential should have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication and must be a non-lactation participant; the male participants agree to use contraception during the study period and for 6 months after the end of the study period.

Who cannot join

  • Hypersensitivity to Atezolizumab
  • Carcinomatous meningitis.
  • History of active Bacillus tuberculosis (TB)
  • Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • HIV positive or with Acquired Immune Deficiency Syndrome
  • Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy
Show all 20Show fewer
  • History of, or any evidence of active, non-infectious pneumonitis
  • Immunosuppressive drug was used 2 weeks prior to the first study drug treatment, excluding topical glucocorticoid, systematic glucocorticoid not exceeding 10 mg/d of prednisone or equivalent dose of other glucocorticoid
  • Received a live vaccine within 30 days of planned start of study therapy
  • Received a prior anti-cancer monoclonal antibody (mAb) within 3 months prior to study day 1
  • Has taken Chinese herbal medicine for anti-cancer purpose in the past 2 weeks
  • Known active hepatitis B (e.g., hepatitis B virus surface antigen [HBsAg] reactive) or hepatitis C (HCV) (e.g., HCV ribonucleic acid [RNA] [qualitative] is detected)
  • Active infection requiring systemic therapy
  • Known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
  • Bleeding tendency, such as active peptic ulcer, or treated with anticoagulants or vitamin K antagonists, such as Warfarin, Heparin, or their analogues
  • Any severe and/or uncontrolled disease, such as: (1) unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months prior to randomization, severe uncontrolled arrhythmia; poor blood pressure control (SBP>140 mmHg, DBP>90 mmHg) ; (2)active or uncontrolled severe infection; (3)liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis; (4) poor control of diabetes (FBG>10mmol/l) ; (5) urine routine suggested urinary protein ≥ + + and 24-hour urinary protein quantitation >1.0 g; (6) history of psychotropic substance abuse and could not be cured or had mental disorder
  • Prisoner who is imprisoned or forcibly detained for reasons other than mental or physical (e.g. infectious) disease
  • Can not tolerate venipuncture
  • Pregnant or lactating women
  • Other conditions that researchers consider unsuitable for participation -

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Hunan cancer hospital

    Changsha, Hunan, 410000

  • the second Xiangya hospital

    Changsha, Hunan, 410000

Other trials in China

About this study

Official title: A Multi-center, Single Arm , Phase II Study of Atezolizumab Combined With Concurrent Chemoradiotherapy and Maintenance Therapy With Atezolizumab in Untreated Participants With Extensive-stage Small Cell Lung Cancer

Etoposide-cisplatin/ -carboplatin in combination with PD-L1 inhibitor for 4 cycles followed by maintenance therapy with PD-L1 inhibitor is currently the world-wide first-line treatment for extensive-stage small cell lung cancer. When 4 cycles of EC/EP chemotherapy combined with PD-L1 inhibitor are effective, guidelines recommend additional thoracic radiotherapy.

In our study, the investigators bring radiotherapy forward, which means that after 2 cycles of EC/EP chemotherapy plus Atezolizumab, participants with response（PR/CR/SD）will receive concurrent radiotherapy and 2 cycles of EC/EP chemotherapy plus Atezolizumab, then maintenance therapy with Atezolizumab （Q3W）.

The purpose of this study is to explore the safety and efficacy of Atezolizumab combined with concurrent chemoradiotherapy in untreated participants with extensive-stage small cell lung cancer.

Read the detailed description

participants receive EC/EP chemotherapy combined with Atezolizumab for 2 cycles, and the efficacy will be evaluated. If the efficacy evaluation is SD/PR/CR, concurrent chemoradiotherapy comined with EC/EP(2 cycles) +Atezolizumab will be initiated. After concurrent chemoradiotherapy +Atezolizumab, Atezolizumab was maintained until PD or intolerance or for at most 2 years.

participants with brain metastases will receive radiotherapy for brain metastases during the first 2 cycles of chemotherapy.

Being tested
Radiation Therapy
Keywords
Extensive-stage small cell lung cancer, PD-L1, Atezolizumab, Concurrent Chemoradiotherapy
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.

  • Radiation TherapyProcedure or surgery

    Thoracic Radiation Dose: 3Gy, QD, total dose: 30-45Gy; Particpants with brain metastases：metastatic lesions≤3:whole brain radiotherapy with local simultaneous PGTV:50Gy/10F；metastatic lesions>3:whole brain radiotherapy PTV:30Gy/10F.

Study groups in NCT04636762
Study groupRoleWhat they receive
Treatment (etoposide, cisplatin, carboplatin, radiation, Atezolizumab)ExperimentalParticipants receive EC/EP chemotherapy combined with Atezolizumab（ PD-L1 inhibitor）for 2 cycles, and the efficacy is evaluated 2 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent chemoradiotherapy with EC/EP(2 cycles) + Atezolizumab） will be initiated. After concurrent chemoradiotherapy+ Atezolizumab, Atezolizumab was maintained until PD or intolerance or for at most 2 years. Participants with brain metastases will receive radiotherapy forbrain metastases during the first 2 cycles of chemotherapy.
Receives: Procedure: Radiation Therapy

What is being measured

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

  1. Number of participants with treatment-related adverse events and the grade of adverse events as assessed by CTCAE v4.0.

    Measured: 0-36month

Secondary outcomes (1)

  1. Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1

    PFS is defined as the period from the start of receiving the first EC/EP chemotherapy plus PD-L1 inhibitor to disease progression.PFS is assessed by the Investigator Using RECIST v1.1.

    Measured: 0-120 months

Timeline

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

  1. First posted19 Nov 2020
  2. Study start1 Jun 2020
  3. Primary completion1 May 2022
  4. Study completion1 May 2022

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
Model description
To assess safety and tolerability of Atezolizumab Combined with Concurrent Chemoradiotherapy and maintenance therapy with Atezolizumab in untreated participants with extensive-disease small cell lung cancer.
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04636762
Sponsor's protocol ID
SCLC-LXL001
Status last verified
Jun 2022
First submitted
8 Nov 2020
Last updated
14 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Liu C, Zeng L, Deng C, Jiang W, Wang Y, Zhou Y, Liu L, Wang S, Zhou C, Qiu Z, Zeng F, Wu F, Weng J, Liu X, Yang N, Ma F. Hypofractionated radiotherapy with immunochemotherapy for extensive-stage small-cell lung cancer. Front Immunol. 2023 Jun 7;14:1175960. doi: 10.3389/fimmu.2023.1175960. eCollection 2023.

    PubMed 37350968

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiation Therapy in people with Extensive-stage Small Cell Lung Cancer, run by Second Xiangya Hospital of Central South University at 2 sites 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 20 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: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 participants with treatment-related adverse events and the grade of adverse events as assessed by CTCAE v4.0. (time frame: 0-36month). 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 NCT04636762, 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 14 Jun 2022.

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