Resectable Locally Advanced Non-small Cell Lung CancerPhase 2ALTER-L043NCT04846634
Penpulimab-based Combination Neoadjuvant/Adjuvant Therapy for Patients With Resectable Locally Advanced Non-small Cell Lung Cancer: a Phase II Clinical Study (ALTER-L043)
A Phase 2 study testing Penpulimab+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel, Penpulimab+Anlotinib+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel and Penpulimab+Anlotinib in people with Resectable Locally Advanced Non-small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a multicenter, randomized, open label, phase II study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Resectable Locally Advanced Non-small Cell Lung Cancer
- What is being tested?
- Penpulimab+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel, Penpulimab+Anlotinib+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel and Penpulimab+Anlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Aug 2021to Feb 2028
- Phase
- Phase 2
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Early stage IIB-IIIB (N2), operable non-small cell lung cancer, confirmed in tissue.
- Epidermal growth factor receptor/anaplastic lymphoma kinase/ROS1 gene fusions mutation was negative in primary tumor or lymph node metastasis.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
- Lung function capacity capable of tolerating the proposed lung surgery.
- Patients had never received surgery, chemotherapy, radiotherapy or biotherapy.
Who cannot join
- Large cell carcinoma and mixed cell lung cancer.
- Any systemic anti-cancer treatment for NSCLC, including cytotoxic drug therapy, immunotherapy, experimental treatment.
- Prior treatment with local radiotherapy.
- Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors).
- Prior treatment with antilotinib and other antiangiogenic drugs.
- History of hypersensitivity to any active or inactive ingredient of Penpulimab, Anlotinib or chemotherapy.
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- Patients with multiple factors affecting oral medication (e.g. inability to swallow, chronic diarrhea, and intestinal obstruction, etc.).
- Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active interstitial lung disease.
- Patients whose tumor has invaded important blood vessels or whose tumor is likely to invade important blood vessels and cause fatal massive hemorrhage during follow-up study.
- Patients who have had arteriovenous thrombosis events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism.
- Pregnant or lactating women.
- History of neurological or mental disorders, including epilepsy or dementia.
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
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Bentong Yu, yubentong@126.com
About this study
This is a multicenter, randomized, open label, phase II study.
Read the detailed description
This is a multicenter, randomized, open label, phase II study assessing the efficacy and safety of penpulimab plus chemotherapy or penpulimab plus anlotinib or penpulimab plus chemotherapy and anlotinib as neoadjuvant/adjuvant treatment in patients with resectable locally advanced non-small cell lung cancer. Eligible patients will be randomized to receive either penpulimab (200mg, iv, Q3W) plus chemotherapy (platinum based chemotherapy) or penpulimab (200mg, iv, Q3W) plus anlotinib (12mg, po, day 1-14, Q3W) or penpulimab (200mg, iv, Q3W) plus chemotherapy (platinum based chemotherapy) and anlotinib (12mg, po, day 1-14, Q3W) in a 1:1:1 ratio.
- Being tested
- Penpulimab+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel, Penpulimab+Anlotinib+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel, Penpulimab+Anlotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penpulimab+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/DocetaxelDrug
Also called Investigational Product
A cycle of treatment is defined as 21 days of once daily treatment.
Penpulimab+Anlotinib+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/DocetaxelDrug
Also called Investigational Product
A cycle of treatment is defined as 21 days of once daily treatment.
Penpulimab+AnlotinibDrug
Also called Investigational Product
A cycle of treatment is defined as 21 days of once daily treatment.
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant Penpulimab + chemotherapy followed by adjuvant Penpulimab | Experimental | Not described Receives: Drug: Penpulimab+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel |
| neoadjuvant Penpulimab + chemotherapy + Anlotinib followed by adjuvant Penpulimab + Anlotinib. | Experimental | Not described Receives: Drug: Penpulimab+Anlotinib+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel |
| neoadjuvant Penpulimab + Anlotinib followed by adjuvant Penpulimab + Anlotinib. | Experimental | Not described Receives: Drug: Penpulimab+Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response (MPR)
Measured: About 3-6 weeks following completion of surgery.
Secondary outcomes (5)
Objective response rate (ORR)
Measured: Within 7 days before surgery.
1 year Event-Free Survival rate
Measured: Up to 5 Years from randomization
Event-Free Survival (EFS)
Measured: Up to 5 years from randomization.
Overall survival (OS)
Measured: Up to 5 years from randomization.
Incidence of adverse events (AEs)/serious adverse events (SAEs)
Measured: Up to 5 Years from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study startAug 2021 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Locally Advanced 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846634
- Sponsor's protocol ID
- ALTER-L043
- Acronym
- ALTER-L043
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 15 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No