Non-squamous Non-small-cell Lung CancerPhase 2NCT04453423
Combination Chemotherapy With or Without Anlotinib in the Maintenance Treatment of Non-Squamous Non-Small Cell Lung Cancer.
A Phase 2 study testing Anlotinib + Pemetrexed+Carboplatin, Pemetrexed and Anlotinib + Pemetrexed in people with Non-squamous Non-small-cell Lung Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
This study will compare maintenance therapy with anlotinib plus pemetrexed versus pemetrexed or anlotinib alone, in patients with Non-squamous Non-small cell lung cancer who have not progressed during first-line therapy with anlotinib + pemetrexed + carboplatin. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-squamous Non-small-cell Lung Cancer
- What is being tested?
- Anlotinib + Pemetrexed+Carboplatin, Pemetrexed and Anlotinib + Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 1 Jul 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
- Age ≥ 18 years and ≤ 75, ECOG PS: 0~1, estimated survival duration more than 3 months;
- Subjects with histologically or cytologically confirmed locally advanced and/or advanced Non-squamous NSCLC;
- Signed and dated informed consent;
- adequate hematological, liver and renal function
Who cannot join
- prior chemotherapy or treatment with another systemic anti-cancer agent
- malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS
- evidence of tumor invading major blood vessels
- current or recent use of aspirin (>325mg/day) or full-dose anticoagulants or thrombolytic agents for therapeutic purposes
- history of haemoptysis >/=grade 2
- clinically significant cardiovascular disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Study of the Effect of Anlotinib, Pemetrexed or the Combination As Maintenance Therapy for Patients With Non-Squamous Non-Small Cell Lung Cancer.
This study will compare maintenance therapy with anlotinib plus pemetrexed versus pemetrexed or anlotinib alone, in patients with Non-squamous Non-small cell lung cancer who have not progressed during first-line therapy with anlotinib + pemetrexed + carboplatin. The primary endpoint of the study is progression-free survival (PFS); the secondary endpoints are disease control rate (DCR), objective response rate (ORR) and overall survival (OS).
- Conditions
- Non-squamous Non-small-cell Lung Cancer
- Being tested
- Anlotinib + Pemetrexed+Carboplatin, Pemetrexed, Anlotinib + Pemetrexed, Anlotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib + Pemetrexed+CarboplatinDrug
Anlotinib: 12mg, QD, PO, d1-14, 21 days per cycle
Carboplatin: AUC 5 on day 1 of 21 days per cycle
Pemetrexed: 500mg/m2 iv on day 1 of 21 days per cycle
PemetrexedDrug
500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)
Anlotinib + PemetrexedDrug
Anlotinib:12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase)
Pemetrexed:500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)
AnlotinibDrug
12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase)
| Study group | Role | What they receive |
|---|---|---|
| First-line Treatment | Other | Not described Receives: Drug: Anlotinib + Pemetrexed+Carboplatin |
| Maintenance Treatment A | Experimental | Not described Receives: Drug: Pemetrexed |
| Maintenance Treatment B | Experimental | Not described Receives: Drug: Anlotinib + Pemetrexed |
| Maintenance Treatment C | Experimental | Not described Receives: Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.
Measured: 6 months
Secondary outcomes (4)
Objective Response Rate (ORR)
Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1). The percentage of patients who achieved CR and PR was defined as objective response rate (ORR).
Measured: each 42 days up to intolerance the toxicity or PD (up to 12 months)
Disease control rate (DCR)
Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1) and the percentage of patients who achieved CR, PR and SD was defined as disease control rate (DCR).
Measured: each 42 days up to intolerance the toxicity or PD (up to 12 months)
Overall Survival (OS)
OS is calculated from diagnosis to death or last follow-up time.
Measured: 12 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Until 30 day safety follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Jul 2020 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-squamous Non-small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453423
- Sponsor's protocol ID
- AN001
- Status last verified
- Jun 2020
- First submitted
- 27 Jun 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effect of Anlotinib, Pemetrexed or the Combination As Maintenance Therapy for Patients With Non-Squamous Non-Small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT04453423
- Acronym / sponsor ID
- AN001
- Conditions
- Non-squamous Non-small-cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 1 Jul 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.
This study will compare maintenance therapy with anlotinib plus pemetrexed versus pemetrexed or anlotinib alone, in patients with Non-squamous Non-small cell lung cancer who have not progressed during first-line therapy with anlotinib + pemetrexed + carboplatin. The primary endpoint of the study is progression-free survival (PFS); the secondary endpoints are disease control rate (DCR), objective response rate (ORR) and overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| First-line Treatment | Other | Drug: Anlotinib + Pemetrexed+Carboplatin |
| Maintenance Treatment A | Experimental | Drug: Pemetrexed |
| Maintenance Treatment B | Experimental | Drug: Anlotinib + Pemetrexed |
| Maintenance Treatment C | Experimental | Drug: Anlotinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years and ≤ 75, ECOG PS: 0~1, estimated survival duration more than 3 months;
- Subjects with histologically or cytologically confirmed locally advanced and/or advanced Non-squamous NSCLC;
- Signed and dated informed consent;
- adequate hematological, liver and renal function
Key exclusion criteria (6 listed)
- prior chemotherapy or treatment with another systemic anti-cancer agent
- malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS
- evidence of tumor invading major blood vessels
- current or recent use of aspirin (>325mg/day) or full-dose anticoagulants or thrombolytic agents for therapeutic purposes
- history of haemoptysis >/=grade 2
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 |
|---|---|---|
| Anlotinib + Pemetrexed+CarboplatinAnlotinib: 12mg, QD, PO, d1-14, 21 days per cycle Carboplatin: AUC 5 on day 1 of 21 days per cycle Pemetrexed: 500mg/m2 iv on day 1 of 21 days per cycle | Drug | First-line Treatment |
| Pemetrexed500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase) | Drug | Maintenance Treatment A |
| Anlotinib + PemetrexedAnlotinib:12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase) Pemetrexed:500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase) | Drug | Maintenance Treatment B |
| Anlotinib12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase) | Drug | Maintenance Treatment C |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 6 months
PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: each 42 days up to intolerance the toxicity or PD (up to 12 months)
Disease control rate (DCR)
Time frame: each 42 days up to intolerance the toxicity or PD (up to 12 months)
Overall Survival (OS)
Time frame: 12 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Until 30 day safety follow-up visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib + Pemetrexed+Carboplatin, Pemetrexed and Anlotinib + Pemetrexed in people with Non-squamous Non-small-cell Lung Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
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 4 inclusion and 6 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 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Renhua Guo, MD (025-68136360, rhguo@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 6 months). 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 1 Jul 2020.