Trials Sponsors Conditions Drugs Pricing

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

Pathological complete response, pCR
To evaluate the pathological complete response rate (pCR) of pembrolizumab combined with anlotinib neoadjuvant therapy for resectable non-small cell lung cancer.
12months

Secondary Outcomes (2)

Major pathologic response, MPR
12months
Disease free survival,DFS
12months

Study Arms (1)

penpulimab combined with anlotinib

EXPERIMENTAL

penpulimab: fixed dose of 200 mg, administered on the first day of each cycle, repeated every 3 weeks; Anlotinib: 12 mg, administered on days 1-14, orally once a day, about half an hour before breakfast (the daily dose should be as much as possible), taken with warm water, and repeated every 3 weeks

Drug: penpulimab combined with anlotinib

Interventions

penpulimab combined with anlotinibDrug

penpulimab combined with anlotinib

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Treatment programme
penpulimab combined with anlotinib
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry record

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

\. 18 years old ≤ age ≤ 70 years old, male or female;
\. ECOG score 0\~1 points;

Sponsors & Collaborators

Tang-Du Hospital
Otherlead

Related Publications (12)

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Non-small Cell Lung Cancer Version 2.2016.
RESULT
McElnay P, Lim E. Adjuvant or neoadjuvant chemotherapy for NSCLC. J Thorac Dis. 2014 May;6 Suppl 2(Suppl 2):S224-7. doi: 10.3978/j.issn.2072-1439.2014.04.26.
PMID: 24868440RESULT
Forde PM, Chaft JE, Smith KN, Anagnostou V, Cottrell TR, Hellmann MD, Zahurak M, Yang SC, Jones DR, Broderick S, Battafarano RJ, Velez MJ, Rekhtman N, Olah Z, Naidoo J, Marrone KA, Verde F, Guo H, Zhang J, Caushi JX, Chan HY, Sidhom JW, Scharpf RB, White J, Gabrielson E, Wang H, Rosner GL, Rusch V, Wolchok JD, Merghoub T, Taube JM, Velculescu VE, Topalian SL, Brahmer JR, Pardoll DM. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 May 24;378(21):1976-1986. doi: 10.1056/NEJMoa1716078. Epub 2018 Apr 16.
PMID: 29658848

MeSH Terms

Interventions

anlotinib

Study Officials

Tao Jiang
Tang-Du Hospital
STUDY CHAIR

Central Study Contacts

Jie Lei

CONTACT

0086-leijiemd@163.com

Jie Lei

CONTACT

leijiemd@163.com

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 18, 2022

First Posted

May 24, 2022

Study Start

June 30, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

April 20, 2023

Estimated (date passed)

You may not qualify if:

\) Subjects who have previously received anti-PD-1 (L1) or CTLA4 monoclonal antibody therapy;
\. Medical history and comorbidities
Suffering from other malignant tumors in the past 3 years;
Suffering from any active autoimmune disease or history of autoimmune disease (as follows, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, Hypothyroidism (may be included after hormone replacement therapy); patients with vitiligo or childhood asthma in complete remission and without any intervention as adults may be included; patients requiring medical intervention with bronchodilators are not included;
The use of immunosuppressive drugs within 14 days before the first use of the study drug, excluding nasal spray and inhaled corticosteroids or systemic steroids at physiological doses (ie, no more than 10 mg/day prednisone or its equivalent) );
Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg despite optimal medical treatment);
Newly diagnosed angina pectoris within 3 months before screening or myocardial infarction within 6 months before screening; arrhythmia (including QTcF: ≥450 ms in males, ≥470 ms in females) requires long-term use of antiarrhythmic drugs and New York Cardiac Association classification ≥ class II cardiac insufficiency; or uncontrolled heart failure;
There is evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiological pneumonia, drug-induced pneumonia, and severely impaired lung function;
Complicated severe infection within 4 weeks before the first dose (eg: need for intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever \>38.5°C during the screening period/before the first dose;
Clinically significant hemoptysis (more than 50 mL of hemoptysis per day) within 3 months before the study, or clinically significant bleeding symptoms or obvious bleeding tendency (such as gastrointestinal bleeding, gastric ulcer bleeding, gastrointestinal bleeding, hemorrhagic gastric Ulcer, fecal occult blood++ or above baseline, or suffering from vasculitis, etc.).
Active bleeding or abnormal coagulation function (INR\>2.0, PT\>16s), with bleeding tendency or receiving thrombolysis, anticoagulation or antiplatelet therapy;
Renal insufficiency: urine routine indicates urine protein ≥ ++, or confirmed 24-hour urine protein amount ≥ 1.0g;
Imaging shows that the tumor has invaded around important blood vessels or the investigator judges that the patient's tumor has a high possibility of invading important blood vessels during treatment and causing fatal hemorrhage;
Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
Administer live attenuated vaccines within 4 weeks before the first dose or plan during the study period;
+11 more criteria

Penpulimab Combined With Anlotinib in Neoadjuvant Treatment of Resectable Non-small Cell Lung Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

penpulimab combined with anlotinib

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (12)

MeSH Terms

Interventions

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

penpulimab combined with anlotinib

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (12)

MeSH Terms

Interventions

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record