Non-small Cell Lung CancerPhase 2/3ATHENANCT04322617
Anlotinib Plus Immune Checkpoint Inhibitors for Lung Cancer
A Phase 2/3 study testing Anlotinib plus the same Immune Checkpoint Inhibitors., Anlotinib plus the new Immune Checkpoint Inhibitors. and Anlotinib in people with Non-small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
Trial summary
This study aims to explore the efficacy of Anlotinib with or without Immune Checkpoint Inhibitor in Standard Chemo-immunotherapy Failed Advanced NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Anlotinib plus the same Immune Checkpoint Inhibitors., Anlotinib plus the new Immune Checkpoint Inhibitors. and Anlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2020to 24 Mar 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
- Age ≥ 18 years.
- Histopathology or cytology confirmed lung cancer
- Failed from first line Chemo-immunotherapy.
- ECOG 0-1.
- Predicted survival ≥ 12 weeks.
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- Adequate bone marrow hematopoiesis and organ function
- Presence of measurable lesions according to RECIST 1.1.
- Subjects with stable brain metastases may be included in the study.
Who cannot join
- Subjects who have received any of the following treatments must be excluded:
- Treatment with molecules such as EGFR, VEGFR antibodies within 4 weeks prior to the first dose of study drug.
- Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.
- Ongoing (or inability to discontinue) possibly potent CYP1A2, CYP3A inhibitor (1 week), or inducer (2 weeks) drug therapy or herbal supplements within 1-2 weeks prior to the first dose.
- Presence of spinal cord compression or meningeal metastasis.
- History of other malignant tumors within 2 years.
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- Adverse events (except alopecia of any degree) of CTCAE > grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
- History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
- The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
- Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.
- Heart-related diseases or abnormalities
- Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.
- Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.
- Live vaccine was given 2 weeks before the first medication.
- Women who are breastfeeding or pregnant.
- Hypersensitivity to the test drug and the ingredients.
- Other conditions assessed by the investigator to be unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yongchang Zhang
Changsha, Hunan, 410013
Yongchang Zhang, MD, +8613873123436 ext. +8613873123436, zhangyongchang@csu.edu.cn
About this study
Official title: Anlotinib With or Without Immune Checkpoint Inhibitors in Standard Chemo-immunotherapy Failed Advanced Non-small Cell Lung Cancer
This study aims to explore the efficacy of Anlotinib with or without Immune Checkpoint Inhibitor in Standard Chemo-immunotherapy Failed Advanced NSCLC.
Read the detailed description
This study aims to explore the efficacy of Anlotinib with or without Immune Checkpoint Inhibitor in Standard Chemo-immunotherapy Failed Advanced NSCLC. The primary endpoint was PFS.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Anlotinib plus the same Immune Checkpoint Inhibitors., Anlotinib plus the new Immune Checkpoint Inhibitors., Anlotinib
- Keywords
- Anlotinib, Immune Checkpoint Inhibitor, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib plus the same Immune Checkpoint Inhibitors.Drug
Also called Pembrolizumab, Sintilimab etc. have been used in the previous treatment.
Anlotinib, 8mg po qd, D1-D14 every 21days.
Anlotinib plus the new Immune Checkpoint Inhibitors.Drug
Also called Pembrolizumab, Sintilimab etc. have not been used in the previous treatment.
Anlotinib, 8mg po qd, D1-D14 every 21days.
AnlotinibDrug
Also called Anlotinib monotherapy.
Anlotinib, 8mg po qd, D1-D14 every 21days.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Anlotinib with the same Immune Checkpoint Inhibitors. | Experimental | Anlotinib plus Immune Checkpoint Inhibitors which has been used in first line treatment. Receives: Drug: Anlotinib plus the same Immune Checkpoint Inhibitors. |
| Cohort B: Anlotinib with the new Immune Checkpoint Inhibitors. | Experimental | Anlotinib plus Immune Checkpoint Inhibitors which has not been used in first line treatment. Receives: Drug: Anlotinib plus the new Immune Checkpoint Inhibitors. |
| Cohort C: Anlotinib Monotherapy. | Experimental | Anlotinib Monotherapy. Receives: Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival time (PFS)
Progression free survival time define as first dose to first documented disease progression assessed by investigator or death due to any cause.
Measured: Time from first subject dose to study completion, or up to 36 month.
Secondary outcomes (2)
Objective Response Rate (ORR)
Objective response rate define as the proportion of subjects who have a complete response (CR) or a partial response (PR).
Measured: Time from first subject dose to study completion, or up to 36 month.
Overall survival (OS)
To assess overall survival, define as first dose to the death of the subject due to any cause.
Measured: Time from first subject dose to study completion, or up to 36 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start24 Mar 2020
- Primary completion24 Mar 2028 (estimated)
- Study completion24 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongchang Zhang, Hunan Province Tumor Hospital
- Investigators
- Yongchang Zhang, MD, Principal investigator, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322617
- Sponsor's protocol ID
- 20200113
- Acronym
- ATHENA
- Status last verified
- Jun 2024
- First submitted
- 24 Mar 2020
- Last updated
- 4 Jun 2024
- 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 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anlotinib With or Without Immune Checkpoint Inhibitors in Standard Chemo-immunotherapy Failed Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04322617
- Acronym / sponsor ID
- ATHENA / 20200113
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Anlotinib, Immune Checkpoint Inhibitor, NSCLC
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- 24 Mar 2028 (estimated)
- Study completion
- 24 Mar 2029 (estimated)
- First posted
- 26 Mar 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 aims to explore the efficacy of Anlotinib with or without Immune Checkpoint Inhibitor in Standard Chemo-immunotherapy Failed Advanced NSCLC.
Detailed description
This study aims to explore the efficacy of Anlotinib with or without Immune Checkpoint Inhibitor in Standard Chemo-immunotherapy Failed Advanced NSCLC. The primary endpoint was PFS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Anlotinib with the same Immune Checkpoint Inhibitors. | Experimental | Drug: Anlotinib plus the same Immune Checkpoint Inhibitors.Anlotinib plus Immune Checkpoint Inhibitors which has been used in first line treatment. |
| Cohort B: Anlotinib with the new Immune Checkpoint Inhibitors. | Experimental | Drug: Anlotinib plus the new Immune Checkpoint Inhibitors.Anlotinib plus Immune Checkpoint Inhibitors which has not been used in first line treatment. |
| Cohort C: Anlotinib Monotherapy. | Experimental | Drug: AnlotinibAnlotinib Monotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
- Age ≥ 18 years.
- Histopathology or cytology confirmed lung cancer
- Failed from first line Chemo-immunotherapy.
- ECOG 0-1.
Key exclusion criteria (17 listed)
- Subjects who have received any of the following treatments must be excluded:
- Presence of spinal cord compression or meningeal metastasis.
- History of other malignant tumors within 2 years.
- Adverse events (except alopecia of any degree) of CTCAE > grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
- History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
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 plus the same Immune Checkpoint Inhibitors.Also: Pembrolizumab, Sintilimab etc. have been used in the previous treatment.Anlotinib, 8mg po qd, D1-D14 every 21days. | Drug | Cohort A: Anlotinib with the same Immune Checkpoint Inhibitors. |
| Anlotinib plus the new Immune Checkpoint Inhibitors.Also: Pembrolizumab, Sintilimab etc. have not been used in the previous treatment.Anlotinib, 8mg po qd, D1-D14 every 21days. | Drug | Cohort B: Anlotinib with the new Immune Checkpoint Inhibitors. |
| AnlotinibAlso: Anlotinib monotherapy.Anlotinib, 8mg po qd, D1-D14 every 21days. | Drug | Cohort C: Anlotinib Monotherapy. |
Primary outcome
Progression free survival time (PFS)
Time frame: Time from first subject dose to study completion, or up to 36 month.
Progression free survival time define as first dose to first documented disease progression assessed by investigator or death due to any cause.
2 secondary outcomes
Objective Response Rate (ORR)
Time frame: Time from first subject dose to study completion, or up to 36 month.
Overall survival (OS)
Time frame: Time from first subject dose to study completion, or up to 36 month.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
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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.
Yongchang Zhang, MD principal investigator
Hunan Cancer Hospital
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 Anlotinib plus the same Immune Checkpoint Inhibitors., Anlotinib plus the new Immune Checkpoint Inhibitors. and Anlotinib in people with Non-small Cell Lung Cancer, run by Hunan Province Tumor Hospital 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 9 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 4 Jun 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongchang Zhang, MD (+8613873123436 ext. +861383123436, zhangyongchang@csu.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 time (PFS) (time frame: Time from first subject dose to study completion, or up to 36 month.). 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 4 Jun 2024.