Not yet recruitingNCT04846634ALTER-L043Updated Apr 15, 2021

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 interventional study of Penpulimab+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel and Penpulimab+Anlotinib+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel in Resectable Locally Advanced Non-small Cell Lung Cancer, sponsored by Tianjin Medical University Cancer Institute and Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-04-15.

Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Mar 2023, 3 years 7 months ago, but the record still lists the study as not yet recruiting.

Phase: Phase 2
Study type: Interventional
Enrollment: 90
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

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.

Conditions studied

Resectable Locally Advanced Non-small Cell Lung Cancer

Browse trials for

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 90 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 90 participants (estimated)

Study arms

Experimental
neoadjuvant Penpulimab + chemotherapy followed by adjuvant Penpulimab
Drug: Penpulimab+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel
Experimental
neoadjuvant Penpulimab + chemotherapy + Anlotinib followed by adjuvant Penpulimab + Anlotinib.
Drug: Penpulimab+Anlotinib+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel
Experimental
neoadjuvant Penpulimab + Anlotinib followed by adjuvant Penpulimab + Anlotinib.
Drug: Penpulimab+Anlotinib

Interventions

DrugPenpulimab+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel
A cycle of treatment is defined as 21 days of once daily treatment.
Also known as: Investigational Product
DrugPenpulimab+Anlotinib+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel
A cycle of treatment is defined as 21 days of once daily treatment.
Also known as: Investigational Product
DrugPenpulimab+Anlotinib
A cycle of treatment is defined as 21 days of once daily treatment.
Also known as: Investigational Product

What researchers measure

Primary outcomes

Major pathological response (MPR)
Time frame: About 3-6 weeks following completion of surgery.

Secondary outcomes

Objective response rate (ORR)
Time frame: Within 7 days before surgery.
1 year Event-Free Survival rate
Time frame: Up to 5 Years from randomization
Event-Free Survival (EFS)
Time frame: Up to 5 years from randomization.
Overall survival (OS)
Time frame: Up to 5 years from randomization.
Incidence of adverse events (AEs)/serious adverse events (SAEs)
Time frame: Up to 5 Years from randomization

Study locations

1 site

The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
- Bentong Yu · Contact · yubentong@126.com

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04846634
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Collaborators: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party: Sponsor
First posted: Apr 15, 2021
Start date: Aug 2021 (estimated)
Primary completion: Mar 2023 (estimated)
Completion: Feb 2028 (estimated)
Last update: Apr 15, 2021

Study contacts

Changli Wang

Contact

wangchangli9@163.com

86-22-23340123 Ext. 6417

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lung Neoplasms→

Other studies from this sponsor

Tianjin Medical University Cancer Institute and Hospital

Start the discussion