Extensive-stage Small Cell Lung CancerPhase 2/3NCT04254471
This Phase II/III, Multicenter Study is Designed to Evaluate the Safety and Clinical Activity of AL3810 in Patients
A Phase 2/3 study testing AL3810 and carboplatin + etoposide in people with Extensive-stage Small Cell Lung Cancer, run by Haihe Biopharma Co., Ltd. at 1 site in China.
Trial summary
Phase II Study is to Evaluate the Safety and tolerability of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC. Phase III Study is to Evaluate the efficacy of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC. 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?
- AL3810 and carboplatin + etoposide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 313 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2019to 22 Nov 2022
- Phase
- Phase 2/3
- 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
- Signed Informed Consent Form
- Male or female, 18 ~75years of age
- Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed ES-SCLC
- No prior treatment for ES-SCLC
- Measurable disease, as defined by RECIST v1.1
- Adequate hematologic and end organ function.
- Serum pregnancy test in screening period for women of childbearing potential should be negative.Except for women who have a history of sterilization or are postmenopausal.Men or woman subjects of reproductive age and their partners must agree to use effective contraception for at least 6 months from the date of signing the Informed Consent Form(ICF) until the last dose of the investigational therapy.
Who cannot join
- Histologically confirmed mixed small cell lung cancer.
- Symptoms related to central nervous system(CNS) metastasis, unstable CNS metastasis, or CNS diseases needed the increase of steroid dosage to control.
- Uncontrolled hypertension.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai
Baohui Han, M.D
About this study
Official title: Multicenter, Phase II/III Study of Carboplatin Plus Etoposide With AL3810 in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)
Phase II Study is to Evaluate the Safety and tolerability of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC.
Phase III Study is to Evaluate the efficacy of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC.
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Being tested
- AL3810, carboplatin + etoposide, Placebo
- 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.
AL3810Drug
Also called Lucitanib, E3810, E-3810
5mgQD, 7.5mgQD, 10mgQD
carboplatin + etoposideDrug
Carboplatin and etoposide are background treatment.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation (AL3810 + carboplatin + etoposide) | Experimental | Phase II:Participants will receive AL3810 orally in combination with carboplatin and etoposide during the Cycles 1-4 . AL3810 dose escalated form 5mg to 10mg step-up to determine the recommended dose of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC. Receives: Drug: AL3810; Drug: carboplatin + etoposide |
| AL3810+ carboplatin + etoposide | Experimental | Phase III:Participants will receive AL3810(recommended dose will be determined by safety monitoring committee (SMC) in Phase II) orally in combination with carboplatin and etoposide during the Cycles 1-4. Thereafter, participants will receive maintenance AL3810 until persistent radiographic PD, intolerable toxicity or withdrawal of consent, investigator's consideration, lost follow up, death ,study termination by the sponsor.whichever occurs first. Receives: Drug: AL3810; Drug: carboplatin + etoposide |
| Placebo+ carboplatin + etoposide | Placebo comparator | Phase III:Participants will receive placebo orally in combination with carboplatin and etoposide during the induction Cycles 1-4. Thereafter, participants will receive maintenance placebo until persistent radiographic PD, intolerable toxicity or withdrawal of consent, investigator's consideration, lost follow up, death ,study termination by the sponsor.whichever occurs first. Receives: Drug: carboplatin + etoposide; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II:adverse event(AE)/serious adverse event(SAE)
AE/SAE to find the recommended dose of AL3810
Measured: From the date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Phase III:1.PFS
- Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1
Measured: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 56 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start14 Nov 2019
- Primary completion22 May 2022 (estimated)
- Study completion22 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-stage Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 313 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haihe Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254471
- Sponsor's protocol ID
- AL3810-301
- Status last verified
- Jan 2020
- First submitted
- 16 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Phase II/III Study of Carboplatin Plus Etoposide With AL3810 in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)
- ClinicalTrials.gov ID
- NCT04254471
- Acronym / sponsor ID
- AL3810-301
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 313 participants (estimated)
- Lead sponsor
- Haihe Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 22 May 2022 (estimated)
- Study completion
- 22 Nov 2022 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II Study is to Evaluate the Safety and tolerability of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC.
Phase III Study is to Evaluate the efficacy of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose escalation (AL3810 + carboplatin + etoposide) | Experimental | Drug: AL3810, Drug: carboplatin + etoposidePhase II:Participants will receive AL3810 orally in combination with carboplatin and etoposide during the Cycles 1-4 . AL3810 dose escalated form 5mg to 10mg step-up to determine the recommended dose of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC. |
| AL3810+ carboplatin + etoposide | Experimental | Drug: AL3810, Drug: carboplatin + etoposidePhase III:Participants will receive AL3810(recommended dose will be determined by safety monitoring committee (SMC) in Phase II) orally in combination with carboplatin and etoposide during the Cycles 1-4. Thereafter, participants will receive maintenance AL3810 until persistent radiographic PD, intolerable toxicity or withdrawal of consent, investigator's consideration, lost follow up, death ,study termination by the sponsor.whichever occurs first. |
| Placebo+ carboplatin + etoposide | Placebo comparator | Drug: carboplatin + etoposide, Drug: PlaceboPhase III:Participants will receive placebo orally in combination with carboplatin and etoposide during the induction Cycles 1-4. Thereafter, participants will receive maintenance placebo until persistent radiographic PD, intolerable toxicity or withdrawal of consent, investigator's consideration, lost follow up, death ,study termination by the sponsor.whichever occurs first. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed Informed Consent Form
- Male or female, 18 ~75years of age
- Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed ES-SCLC
- No prior treatment for ES-SCLC
Key exclusion criteria (3 listed)
- Histologically confirmed mixed small cell lung cancer.
- Symptoms related to central nervous system(CNS) metastasis, unstable CNS metastasis, or CNS diseases needed the increase of steroid dosage to control.
- Uncontrolled hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AL3810Also: Lucitanib, E3810, E-38105mgQD, 7.5mgQD, 10mgQD | Drug | AL3810+ carboplatin + etoposide, Dose escalation (AL3810 + carboplatin + etoposide) |
| carboplatin + etoposideCarboplatin and etoposide are background treatment. | Drug | AL3810+ carboplatin + etoposide, Dose escalation (AL3810 + carboplatin + etoposide), Placebo+ carboplatin + etoposide |
| PlaceboPlacebo | Drug | Placebo+ carboplatin + etoposide |
Primary outcome
Phase II:adverse event(AE)/serious adverse event(SAE)
Time frame: From the date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
AE/SAE to find the recommended dose of AL3810
Phase III:1.PFS
Time frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 56 months
1. Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing AL3810 and carboplatin + etoposide in people with Extensive-stage Small Cell Lung Cancer, run by Haihe Biopharma Co., Ltd. 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 3 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 5 Feb 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yixing Chen (+ 86-(021)-2056 8989 ext. 8903, yixing.chen@haihepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase II:adverse event(AE)/serious adverse event(SAE) (time frame: From the date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 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?
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 5 Feb 2020.