AzTrials
AzTrials

Non Small Cell Lung CancerPhase 2NCT05460481

Anlotinib Plus Penpulimab in Advanced Non-Small-Cell Lung Cancer Previously Treated With PD-1/PD-L1 Inhibitors

A Phase 2 study testing Anlotinib Plus Penpulimab in people with Non Small Cell Lung Cancer, run by Hunan Cancer Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor cell proliferation related kinase -c-Kit kinase. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Anlotinib Plus Penpulimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteChina
Study dates
12 Jun 2022to Dec 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

  • Signed and dated informed consent
  • Non Small cell lung cancer pathologically confirmed, with measurable nidus (RECIST 1.1)
  • Disease progression following prior Immune Checkpoint Inhibitors (PD-1 or PD-L1 inhibitors) treatment for NSCLC for at least 2 consecutive treatment cycles.
  • EGFR/ALK/ROS1 wild type
  • ECOG PS: 0-1, Expected Survival Time: Over 3 months
  • Adequate bone marrow, liver and renal function
  • The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 8 weeks after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 8 weeks after it.

Who cannot join

  • Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non small cell cancer)
  • Have used Anlotinib or other antiangiogenic drugs before
  • Known primary multidrug resistance to prior ICIs treatments
  • Have failed for two times or beyond of platinum two drugs chemotherapy (except adjunctive chemotherapy, neoadjuvant therapy and concurrent chemoradiotherapy
  • Iconography (CT or MRI) shows obvious lung empty or necrotic tumor iconography (CT or MRI) shows that the tumor vessels have 5 mm or less, or Cardiovascular involvement by Central tumor; Or obvious lung empty or necrotic tumor
  • Patients with brain or central nervous system metastases, including leptomeningeal disease, or CT/MRI examination revealed brain or leptomeningeal disease） (28 days before the random treatment has been completed and the symptoms of patients with brain metastases from stable can into the group, but need to the cerebral MRI, CT or vein angiography confirmed as without symptoms of cerebral hemorrhage)
Show all 26Show fewer
  • Patients are participating in other clinical studies (other than non-interventional studies) less than 4 weeks from the end of the previous clinical study
  • Patients who had received chemotherapy, radiation, or other experimental anticancer therapy (except Diphosphonate) within 4 weeks prior to the first dose of this study. Those who had previously received local radiotherapy were eligible if they met the following criteria: the end of radiotherapy was more than 4 weeks from the start of this study (brain radiotherapy was more than 2 weeks); In addition, the target lesions selected in this study were not in the radiotherapy area, or if the target lesion is within the radiotherapy area but progression has been confirmed
  • Other kinds of malignancies within 5 years or for now
  • Patients who have an active, known or suspected autoimmune disease, including a history of allogeneic organ transplantation, allogeneic hematopoietic stem cell transplantation, a history of being HIV positive, or a history of acquired immunodeficiency syndrome (AIDS)
  • Active or previously recorded inflammatory bowel disease (such as Crohn's disease, ulcerative colitis)
  • Have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
  • Abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency or be treated with thrombolysis and anticoagulation
  • Have clinical significant hemoptysis occurred within 3 months before enrollment (daily hemoptysis more than half tablespoonl; Or clinical significant bleeding symptoms or bleeding tendency in the 4 weeks prior to grouping, such as gastrointestinal bleeding, hemorrhagic gastric ulcer (including gastrointestinal perforation and/or fistula, but gastrointestinal perforation or fistula has been surgically removed, admission is allowed), baseline fecal occulted blood ++ or above, unhealed wounds, ulcers or fractures, etc
  • Urine routines show urine protein≥ ++, and urine protein quantity≥ 1.0 g during 24 hours
  • Uncontrollable hypertensive (SBP≥ 150 mmHg, DBP≥100 mmHg, despite the best drug treatment)
  • Patients with severe cardiovascular disease: grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia; According to NYHA standard, grade III to IV cardiac insufficiency, or echocardiography indicates left ventricular ejection fraction (LVEF) < 50%;
  • Patients with NCI-CTCAE grade II or greater peripheral neuropathy, except due to trauma
  • Interstitial lung disease, uncontrolled medium to large serosal effusion (including pleural effusion, ascites, and pericardial effusion) after pumping treatment, aggravated chronic obstructive pulmonary disease, active pulmonary infection and/or acute bacterial or fungal respiratory disease requiring intravenous antibiotic treatment within 28 days
  • Have an obvious factor influencing oral drug absorption, such as unable to swallow, chronic diarrhea and intestinal obstruction, etc
  • Have venous thromboembolism events within 6 months before enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc
  • Have received live or attenuated vaccine within 30 days prior to the initial administration of Penpulimab, or was scheduled to receive live or attenuated vaccine during the study
  • Patients who have known a history of severe hypersensitivity to other monoclonal antibodies
  • Patients who have known a history of psychotropic substance abuse, alcohol abuse, or drug abuse
  • Uncontrolled active hepatitis after treatment (hepatitis b: HBsAg positive and HBV DNA more than 1 x 104 copy /ml; Hepatitis c: HCV RNA is positive and liver function is abnormal); Combined with hepatitis b and hepatitis c infection
  • Serious diseases that endanger patients' safety or affect patients' completion of research, according to the researchers' judgment

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Hunan Cancer hospital

    Changsha, Hunan, 410000

    Lin Wu, Professor, 008613170419973, wulin-calf@vip.163.com

    Recruiting

Other trials in China

About this study

Official title: Anlotinib Plus Penpulimab in Advanced Non-Small-Cell Lung Cancer Previously Treated With PD-1/PD-L1 Inhibitors: A Multicenter, Single-arm, Explorative Trial

Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor cell proliferation related kinase -c-Kit kinase. In the phase # study, patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib or placebo, the anlotinib group PFS and OS were 5.37 months and 9.63 months, the placebo group PFS and OS were 1.4 months and 6.3 months. Therefore, the combination of Anlotinib and Penpulimab (a new PD-1 inhibitor) is attempted for the treatment of advanced non-small-cell lung cancer (NSCLC) participants who have progressed following prior PD-1 or PD-L1 Inhibitors treatment, to further improve the patient's PFS or OS.

Read the detailed description

This is a multicenter, single-arm, explorative clinical trial conducted in China to investigate the efficacy and safety of anlotinib plus docetaxel in advanced NSCLC patients (pts) who have progressed following prior PD-1 or PD-L1 Inhibitors treatment.

Being tested
Anlotinib Plus Penpulimab
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 PenpulimabDrug

    Also called Anlotinib & Penpulimab

    Anlotinib: 10mg orally daily on day 1 to 14 of a 21-day cycle. Penpulimab: 200mg by intravenous drip on day 1 of a 21-day cycle.

Study groups in NCT05460481
Study groupRoleWhat they receive
Experimental: Anlotinib Plus PenpulimabExperimentalAnlotinib (10mg qd po d1-14, 21 days per cycle) and Penpulimab (200mg ivgtt d1)
Receives: Drug: Anlotinib Plus Penpulimab

What is being measured

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

  1. Objective Response Rate (ORR)

    Objective Response Rate per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

    Measured: up to approximately 24 months

Secondary outcomes (4)

  1. Progress free survival (PFS)

    Progress free survival per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

    Measured: up to approximately 24 months

  2. Overall Survival (OS)

    Overall Survival per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

    Measured: up to approximately 24 months

  3. Disease Control Rate (DCR)

    Disease Control Rate per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

    Measured: up to approximately 24 months

  4. Safety

    Safety as measured by the rate of AEs, SAEs and laboratory abnormalities

    Measured: From the first assignment of informed consent form up to 21 days after the last dose

Timeline

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

  1. First posted15 Jul 2022
  2. Study start12 Jun 2022
  3. Primary completionJun 2023 (estimated)
  4. Study completionDec 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
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05460481
Sponsor's protocol ID
ALTER-L045
Status last verified
Jul 2022
First submitted
12 Jul 2022
Last updated
20 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib Plus Penpulimab in people with Non Small Cell Lung Cancer, run by Hunan Cancer 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 7 inclusion and 26 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 20 Jul 2022. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: up to approximately 24 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 NCT05460481.

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 20 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in