NSCLCPhase 4pcwaintrlNCT05387109

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

A Phase 4 study testing penpulimab combined with anlotinib in people with NSCLC, run by Tang-Du Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

Neoadjuvant therapy with penpulimab combined with anlotinib;with surgery within 4-6 weeks after drug withdrawal;Adjuvant therapy within 4-12 weeks after surgery Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: NSCLC
What is being tested?: penpulimab combined with anlotinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: No sites listed yet
Study dates: 30 Jun 2022to 20 Apr 2024
Phase: Phase 4
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. 18 years old ≤ age ≤ 70 years old, male or female;
2. ECOG score 0~1 points;
3. Patients with non-small cell lung cancer diagnosed by pathology (histology or cytology) (according to WHO 2015 classification);
4. Patients with positive PD-L1 expression (PD-L1≥1%);
5. According to the eighth edition of clinical tumor TNM staging, the subjects are patients with resectable stage II-IIIB (IIIB only T3N2) non-small cell lung cancer;
6. Have measurable lesions (according to RECIST 1.1 standard, the long diameter of CT scan of tumor lesions is ≥10mm, and the short diameter of CT scan of lymph node lesions is ≥15mm;);

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7. Those who were initially diagnosed with non-small cell lung cancer before enrollment and had not undergone radiotherapy, chemotherapy, surgery and targeted therapy;
8. The subject must have sufficient cardiopulmonary function for the intended lung resection;
9. The function of major organs is normal, that is, the following criteria are met:
Routine blood examination must meet the following requirements (no blood transfusion, no hematopoietic factor and no drug correction within 14 days):
ANC ≥1.5×109/L;
PLT ≥ 100×109/L;
HB ≥ 90 g/L;
The biochemical examination must meet the following standards:
TBIL≤1.5×ULN;
ALT, AST≤2.5×ULN
Serum creatinine sCr≤1.5×ULN, endogenous creatinine clearance rate≥50mL/min (Cockcroft-Gault formula);
ALB ≥30 g/L
Coagulation function must meet: INR≤1.5×ULN and APTT≤1.5×ULN;
10. Normal lung function or mild to moderate abnormality, and can tolerate surgery;
VC%>60%
FEV1>1.2L, FEV1%>40%
DLco>40%
11. Female subjects of childbearing age must undergo a serum pregnancy test within 3 days before starting the study drug, and the result is negative, and are willing to use a medically approved high-efficiency contraceptive during the study and within 3 months after the last dose of the study drug Measures (eg: IUD, contraceptives, or condoms); for male subjects whose partners are females of childbearing age, surgical sterilization, or consent to use an effective method of contraception.

Who cannot join

1. Target disease exclusion criteria
1) Subjects who have previously received anti-PD-1 (L1) or CTLA4 monoclonal antibody therapy;
2. 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) );

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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;
Patients with central squamous cell carcinoma diagnosed by imaging examination and pathological examination;
3. Physical examination and laboratory findings
Patients with congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (positive hepatitis C antibody, and high HCV-RNA) (the lower limit of detection of the analytical method) or co-infection with hepatitis B and C;
Pregnant or breastfeeding women; patients with childbearing potential who are unwilling or unable to take effective contraceptive measures;
Those who are known to be positive for EGFR/ALK gene mutation, and those whose EGFR/ALK gene mutation status is unknown are not required to be tested;
4. Allergies, anaphylaxis and adverse drug reactions
Severe allergic reactions to other monoclonal antibodies;
Allergy or intolerance to infusion;
Have a history of severe allergy to Anlotinib or its preventive medicines;
5. Subjects who are participating in other clinical studies or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or 5 half-lives of the research drug;
6. The subject is known to have a history of psychotropic substance abuse, alcohol or drug abuse; The investigator believes that there are any conditions that may harm the subject or prevent the subject from meeting or performing the research requirements.

Trial locations and contacts

No sites are listed yet.

Jie Lei contact

0086-

leijiemd@163.com

Jie Lei contact

leijiemd@163.com

About this study

Official title: An Exploratory Study of Penpulimab Combined With Anlotinib in Neoadjuvant Treatment of Resectable Stage II-IIIB Non-small Cell Lung Cancer

Neoadjuvant therapy with penpulimab combined with anlotinib;with surgery within 4-6 weeks after drug withdrawal;Adjuvant therapy within 4-12 weeks after surgery

Read the detailed description

Neoadjuvant therapy with penpulimab combined with anlotinib 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.
operation treatment: Each subject will receive 3 cycles of study treatment, with surgery within 4-6 weeks after drug withdrawal.
Suggested dosing regimen in the adjuvant therapy phase:

It is recommended to give patients corresponding adjuvant therapy after surgery, and the specific adjuvant therapy plan will be formulated by the investigator according to the individual situation of the patient. The postoperative adjuvant therapy in this protocol is for reference only: complete pre-dose examination within 4-12 weeks after surgery, and conduct pre-administration evaluation of adjuvant therapy; use platinum-based chemotherapy (cisplatin: 75mg/m2, d1, Q3W, 4 cycles; in combination with docetaxel: 75mg/m2, d1, Q3W, 4 cycles, or in combination with pemetrexed: 500mg/m2, d1, Q3W, 4 cycles (for non-squamous cell carcinoma only) row 4 cycle of adjuvant therapy; then continued adjuvant single-agent penicillimab (200 mg, day 1, Q3W) for 1 year or until disease progression.

If the following conditions occur during the treatment, such as the subject's disease progression, drug toxicity and side effects intolerable, withdrawal of informed consent, etc., the patient will terminate the treatment. During the trial, the efficacy indicators and safety indicators were observed.

Conditions: NSCLC
Being tested: penpulimab combined with anlotinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

penpulimab combined with anlotinibDrug
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

Study groups in NCT05387109
Study group	Role	What they receive
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 Receives: Drug: penpulimab combined with anlotinib

What is being measured

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

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.
Measured: 12months

Secondary outcomes (2)

Major pathologic response, MPR
Evaluate the major pathologic response rate (MPR)
Measured: 12months
Disease free survival,DFS
defined as, according to the RECIST1.1 criteria, the time between subjects from enrollment to disease recurrence or death (for any reason)
Measured: 12months

Timeline

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

30 Jun 202220 Apr 2024

First posted24 May 2022
Study start30 Jun 2022 (estimated)
Primary completion20 Apr 2023 (estimated)
Study completion20 Apr 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for NSCLCStudies of the same condition, open and under way.
More trials run by Tang-Du HospitalThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 41 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05387109
Sponsor's protocol ID: TQXB-L-II-001
Acronym: pcwaintrl
Status last verified: May 2022
First submitted: 18 Apr 2022
Last updated: 24 May 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Non-small Cell Lung Cancer Version 2.2016.
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.
PubMed 24868440
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.
PubMed 29658848
Rusch V W, Chaft J E, Johnson B, et al. Neoadjuvant atezolizumab in resectable non-small cell lung cancer (NSCLC): Initial results from a multicenter study (LCMC3)[J]. Journal of Clinical Oncology, 2018, 36, 8541. DOI: 10.1200/JCO. 2018.36.15_suppl.8541.
Cascone T, William W N, Weissferdt A, et al. LBA49 Neoadjuvant nivolumab (N) or nivolumab plus ipilimumab (NI) for resectable non-small cell lung cancer (NSCLC)[J]. Annals of Oncology, 2018, 29(suppl_8): mdy424. 059.
Provencio-Pulla M, Nadal-Alforja E, Cobo M, et al. Neoadjuvant chemo/immunotherapy for the treatment of stages IIIA resectable non-small cell lung cancer (NSCLC): A phase II multicenter exploratory study-NADIM study-SLCG [J]. Journal of Clinical Oncology, 2018, 36, 8521. DOI: 10.1200/JCO. 2018.36.15_suppl.8521.
Jonathan Spicer, Changli Wang, Fumihiro Tanaka, et al. Surgical outcomes from the phase 3 CheckMate 816 trial: Nivolumab (NIVO) + platinum-doublet chemotherapy (chemo) vs chemo alone as neoadjuvant treatment for patients with resectable non-small cell lung cancer (NSCLC) [J]. 2021, ASCO, abstract 8503.
Zhao X, Su Y, You J, Gong L, Zhang Z, Wang M, Zhao Z, Zhang Z, Li X, Wang C. Combining antiangiogenic therapy with neoadjuvant chemotherapy increases treatment efficacy in stage IIIA (N2) non-small cell lung cancer without increasing adverse effects. Oncotarget. 2016 Sep 20;7(38):62619-62626. doi: 10.18632/oncotarget.11547.
PubMed 27566586
Chaft JE, Rusch V, Ginsberg MS, Paik PK, Finley DJ, Kris MG, Price KA, Azzoli CG, Fury MG, Riely GJ, Krug LM, Downey RJ, Bains MS, Sima CS, Rizk N, Travis WD, Rizvi NA. Phase II trial of neoadjuvant bevacizumab plus chemotherapy and adjuvant bevacizumab in patients with resectable nonsquamous non-small-cell lung cancers. J Thorac Oncol. 2013 Aug;8(8):1084-90. doi: 10.1097/JTO.0b013e31829923ec.
PubMed 23857398
Mislang A, Coward J, Cooper A, et al. 157P Efficacy and safety of penpulimab (AK105), a new generation anti-programmed cell death-1 (PD-1) antibody, in upper gastrointestinal cancers [J]. Annals of Oncology, 2020, 31.
Kotasek D, Coward J, Souza P, et al. A phase I dose escalation and dose expansion study of the anti-programmed cell death-1 (PD-1) antibody AK105 [J]. Journal of Clinical Oncology, 2019, 37(15_suppl): e14006-e14006.
Song Y, Zhu J, Lin N, et al. A phase I/II study of the anti-programmed cell death-1 (PD-1) antibody AK105 in patients with relapsed or refractory classic Hodgkin lymphoma (cHL) [J]. Journal of Clinical Oncology, 2019, 37(15_suppl): e19017-e19017.

Study at a glance

From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Study of Penpulimab Combined With Anlotinib in Neoadjuvant Treatment of Resectable Stage II-IIIB Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT05387109
Acronym / sponsor ID: pcwaintrl / TQXB-L-II-001
Conditions: NSCLC
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 41 participants (estimated)
Lead sponsor: Tang-Du HospitalUniversity, hospital or other
Study start: 30 Jun 2022 (estimated)
Primary completion: 20 Apr 2023 (estimated)
Study completion: 20 Apr 2024 (estimated)
First posted: 24 May 2022 (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.

Neoadjuvant therapy with penpulimab combined with anlotinib;with surgery within 4-6 weeks after drug withdrawal;Adjuvant therapy within 4-12 weeks after surgery

Detailed description

Neoadjuvant therapy with penpulimab combined with anlotinib 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.
operation treatment: Each subject will receive 3 cycles of study treatment, with surgery within 4-6 weeks after drug withdrawal.
Suggested dosing regimen in the adjuvant therapy phase:

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
penpulimab combined with anlotinib	Experimental	Drug: penpulimab combined with anlotinibpenpulimab: 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

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (24 listed)

1. 18 years old ≤ age ≤ 70 years old, male or female;
2. ECOG score 0~1 points;
3. Patients with non-small cell lung cancer diagnosed by pathology (histology or cytology) (according to WHO 2015 classification);
4. Patients with positive PD-L1 expression (PD-L1≥1%);
5. According to the eighth edition of clinical tumor TNM staging, the subjects are patients with resectable stage II-IIIB (IIIB only T3N2) non-small cell lung cancer;

Key exclusion criteria (27 listed)

1. Target disease exclusion criteria
1) Subjects who have previously received anti-PD-1 (L1) or CTLA4 monoclonal antibody therapy;
2. Medical history and comorbidities
3. Physical examination and laboratory findings
4. Allergies, anaphylaxis and adverse drug reactions

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
penpulimab combined with anlotinibpenpulimab: 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

Primary outcome

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

2 secondary outcomes

Major pathologic response, MPR
Time frame: 12months
Disease free survival,DFS
Time frame: 12months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
Results publicationNCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Non-small Cell Lung Cancer Version 2.2016.
Results publication: PubMed 24868440McElnay 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.
Results publication: PubMed 29658848Forde 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.
Results publicationRusch V W, Chaft J E, Johnson B, et al. Neoadjuvant atezolizumab in resectable non-small cell lung cancer (NSCLC): Initial results from a multicenter study (LCMC3)[J]. Journal of Clinical Oncology, 2018, 36, 8541. DOI: 10.1200/JCO. 2018.36.15_suppl.8541.
Results publicationCascone T, William W N, Weissferdt A, et al. LBA49 Neoadjuvant nivolumab (N) or nivolumab plus ipilimumab (NI) for resectable non-small cell lung cancer (NSCLC)[J]. Annals of Oncology, 2018, 29(suppl_8): mdy424. 059.
Results publicationProvencio-Pulla M, Nadal-Alforja E, Cobo M, et al. Neoadjuvant chemo/immunotherapy for the treatment of stages IIIA resectable non-small cell lung cancer (NSCLC): A phase II multicenter exploratory study-NADIM study-SLCG [J]. Journal of Clinical Oncology, 2018, 36, 8521. DOI: 10.1200/JCO. 2018.36.15_suppl.8521.
Results publicationJonathan Spicer, Changli Wang, Fumihiro Tanaka, et al. Surgical outcomes from the phase 3 CheckMate 816 trial: Nivolumab (NIVO) + platinum-doublet chemotherapy (chemo) vs chemo alone as neoadjuvant treatment for patients with resectable non-small cell lung cancer (NSCLC) [J]. 2021, ASCO, abstract 8503.
Results publication: PubMed 27566586Zhao X, Su Y, You J, Gong L, Zhang Z, Wang M, Zhao Z, Zhang Z, Li X, Wang C. Combining antiangiogenic therapy with neoadjuvant chemotherapy increases treatment efficacy in stage IIIA (N2) non-small cell lung cancer without increasing adverse effects. Oncotarget. 2016 Sep 20;7(38):62619-62626. doi: 10.18632/oncotarget.11547.
Results publication: PubMed 23857398Chaft JE, Rusch V, Ginsberg MS, Paik PK, Finley DJ, Kris MG, Price KA, Azzoli CG, Fury MG, Riely GJ, Krug LM, Downey RJ, Bains MS, Sima CS, Rizk N, Travis WD, Rizvi NA. Phase II trial of neoadjuvant bevacizumab plus chemotherapy and adjuvant bevacizumab in patients with resectable nonsquamous non-small-cell lung cancers. J Thorac Oncol. 2013 Aug;8(8):1084-90. doi: 10.1097/JTO.0b013e31829923ec.
Results publicationMislang A, Coward J, Cooper A, et al. 157P Efficacy and safety of penpulimab (AK105), a new generation anti-programmed cell death-1 (PD-1) antibody, in upper gastrointestinal cancers [J]. Annals of Oncology, 2020, 31.
Results publicationKotasek D, Coward J, Souza P, et al. A phase I dose escalation and dose expansion study of the anti-programmed cell death-1 (PD-1) antibody AK105 [J]. Journal of Clinical Oncology, 2019, 37(15_suppl): e14006-e14006.
Results publicationSong Y, Zhu J, Lin N, et al. A phase I/II study of the anti-programmed cell death-1 (PD-1) antibody AK105 in patients with relapsed or refractory classic Hodgkin lymphoma (cHL) [J]. Journal of Clinical Oncology, 2019, 37(15_suppl): e19017-e19017.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Jie Lei contact

0086-

leijiemd@163.com

Jie Lei contact

leijiemd@163.com

Tao Jiang study chair

Tang-Du Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing penpulimab combined with anlotinib in people with NSCLC, run by Tang-Du Hospital.

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 24 inclusion and 27 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 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Contact Jie Lei (0086-, leijiemd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response, pCR (time frame: 12months). 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 NCT05387109, which also lists 12 linked publications.

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 24 May 2022.