The Efficacy and Safety of PD-1/PD-L1 Inhibitors Combined With Centipeda Minima (CM) in Lung Cancer

NCT05735028 | Recruiting Phase 1

• 1 other identifier: 2022-0826
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer has a high global cancer morbidity and mortality. At present, PD-1/PD-L1 inhibitors have been approved by FDA to treat different types of lung cancer, but the efficacy is not good. There is an urgent need to develop drugs that can significantly enhance the efficacy of PD-1/PD-L1 inhibitors to enable tumor patients to obtain lasting anti-tumor response. Centipeda minima (CM), as a commonly used traditional Chinese medicine, is relatively safe. Previous studies found that it can inhibit the growth of lung cancer cells. At the level of animal research, the combined use of CM and PD-1/PD-L1 inhibitors produced a stronger anti-lung cancer effect, and did not produce obvious side effects on mice. Based on previous studies, the main purpose of this study was to evaluate the efficacy and safety of PD-1/PD-L inhibitors combined with herbivorous herbivores (CM) in the treatment of lung cancer.

Conditions

Lung Cancer

Keywords

lung cancer; Centipeda minima; efficacy; safty

Outcome Measures

Primary Outcomes (5)

• Progression-free survival (PFS)

  Progression-free survival

  through study completion, an average of 2 year.

• the temperature

  Vital signs

  through study completion, an average of 2 year.

• blood pressure

  Vital signs

  through study completion, an average of 2 year.

• complete blood count

  laboratory index

  through study completion, an average of 2 year.

• adverse event and severe adverse event

  adverse event and severe adverse event, according to NCI-CTC V5.0

  through study completion, an average of 2 year.

Secondary Outcomes (2)

• Objective Response Rate (ORR)

  through study completion, an average of 2 year.

• disease control rate (DCR)

  through study completion, an average of 2 year.

Study Arms (2)

CM group

EXPERIMENTAL

CM+PD-1/PD-L1 inhibitor

Drug: Centipeda minima+PD-1/PD-L1 inhibitor

Control group

ACTIVE COMPARATOR

PD-1/PD-L1 inhibitor

Drug: PD-1/PD-L1 inhibitor

Interventions

Centipeda minima+PD-1/PD-L1 inhibitor DRUG

Before routine anti-PD-1/PD-L1 treatment, patients were treated with Centipeda minima, and15g Centipeda minima decoction was taken twice a day for 5 consecutive days.

CM group

PD-1/PD-L1 inhibitor DRUG

PD-1/PD-L1 inhibitor

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with non-small cell lung cancer diagnosed by histopathology and intended to be treated with PD-1/PD-L1 inhibitors alone meet the following conditions:
• Patients fully understand this study and voluntarily participate in and sign informed consent.
• Patients with non-small cell lung cancer (NSCLC) confirmed by histopathology will be treated with PD-1/PD-L1 alone.
• years old, and the expected survival time is more than 6 months.
• The indexes of stool routine are normal.

You may not qualify if:

• Patients who plan to receive other traditional Chinese medicine treatment at the same time during the study period.
• Those who are hypersensitive to any research drugs or ingredients
• Those who have severe acute infection and are not controlled; or those who have suppurative and chronic infection and whose wounds are not healed.
• Obvious gastrointestinal diseases during screening, such as inability to swallow, chronic diarrhea, intestinal obstruction, gastric ulcer and so on.
• Those who have participated in clinical trials of other drugs within 5 or 4 weeks.
• Patients with severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmias, unstable angina pectoris, myocardial infarction, severe valvular heart disease and intractable hypertension.
• Suffering from uncontrollable neurological, mental illness or mental disorders, poor compliance, unable to cooperate and describe the treatment response. Primary brain tumor or central nervous system metastasis is not controlled, with obvious intracranial hypertension or neuropsychiatric symptoms.
• Those with bleeding tendency; evidence of hereditary hemorrhagic physique or blood coagulation disorder
• Severe allergic / allergic reaction to humanized antibody.
• Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to the first administration of the study, allowing the use of physiological doses of glucocorticoids (prednisone or equivalent for ≤ 10mg/ days).
• Exclude subjects with active, known or suspected autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hypothyroidism, including but not limited to these diseases or syndromes).
• Vulnerable groups: such as patients with serious diseases, incapacitated, illiterate, mentally retarded / related mental disorders, children.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Ying Dong, Doctorate

  2ndAffiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Dong, Doctorate

CONTACT

13666669105; dongying74@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 21, 2023
• Study Start: February 7, 2024
• Primary Completion: August 7, 2025
• Study Completion: December 7, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)