Clinical Study of Camrelizumab Combined With APatinib and Albumin Paclitacxel in Patients With Advanced Lung Adenocarcinoma

NCT04459078 | Unknown Phase 2

• 1 other identifier: CAPAP-lung
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 3

Brief Summary

This study is a single arm, open label, national multicenter study, to explore the efficacy and safety of the combination of Camrelizumab, apatinib and albumin paclitaxel in advanced untreated EGFR Wild Type and ALK-negative Lung Adenocarcinoma. The study does not consider PD-L1 expression, but tumor samples need to be explored by PD-L1 detection and other exploratory analysis.

Conditions

Adenocarcinoma of the Lung

Keywords

immunotherapy; PD-1 checkpoint inhibitor; Anti-angiogenesis; First-line Treatment

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression free survival (PFS) evaluated by investigators based on the RECIST 1.1 criteria.

  Up to 24 months

Secondary Outcomes (6)

• ORR

  Up to 24 months

• OS

  Up to 24 months

• DCR

  Up to 24 months

• DOR

  Up to 24 months

• The change of quality of life

  Up to 24 months

Study Arms (1)

Camrelizumab combined with Albumin Paclitacxel and Apatinib.

EXPERIMENTAL

Participants are given intravenous administration of Camrelizumab (200mg/3w) in addition with intravenous administration of Albumin Paclitacxel (135mg/m2, d1, d8/3w, 4-6 cycles) and Apatinib (250mg Qd po for 5 days,, take rest for 2 days every week). Treatment terminates when disease progression, death or unacceptable toxicity.

Drug: Camrelizumab; Drug: Albumin Paclitacxel; Drug: Apatinib

Interventions

Camrelizumab DRUG

Intravenous administration of (200mg/3weeks)

Also known as: SHR1210, PD-1 inhibitor

Camrelizumab combined with Albumin Paclitacxel and Apatinib.

Albumin Paclitacxel DRUG

intravenous administration of Albumin Paclitacxel (135mg/m2, d1, d8/3w, 4-6 cycles)

Also known as: Chemotherapy drug

Camrelizumab combined with Albumin Paclitacxel and Apatinib.

Apatinib DRUG

Patients will be given oral of Apatinib (250mg Qd po for 5 days, take rest for 2 days every week)

Also known as: Anti-angiogenesis drug

Camrelizumab combined with Albumin Paclitacxel and Apatinib.

Eligibility Criteria

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

You may qualify if:

• \. Age\>=18 years, both men and women can be enrolled 2. Histologically confirmed adenocarcinoma (does not contain small cell components).
• \. Locally advanced, untreated recurrent or metastatic lung adenocarcinoma not suitable for radical surgery or radiotherapy. Previous neoadjuvant and adjuvant radiochemotherapy can be accepted (chemotherapy/radiotherapy, non-immunotherapy), tumor progression ≥6 months before the end of neoadjuvant / adjuvant therapy is required .
• \. ECOG score of physical condition was 0-1, and there was no deterioration in the first 2 weeks. Expected survival over 12 weeks.
• \. According to the RECIST1.1 criteria, it is required that at least one measurable treatment naive lesion (has not been treated with radiotherapy in the past and will not receive local therapy such as radiotherapy throughout the treatment); If the lesion has been treated with radiotherapy then the progress of this lesion need to be confirmed by imaging, before being used as the target lesion.
• \. Laboratory certified by CAP reported negative in EGFR and ALK mutation-sensitive mutations.
• \. Clinical laboratory examination indicators meet the following standards:
• Platelet ≥100×109/L
• Absolute neutrophil count (ANC) ≥1.5×109/L, or absolute white blood cell count (WBC) ≥3.5×109/L
• Hemoglobin (Hgb) ≥ 100 g/L (without blood transfusion or erythropoietin use within 4 weeks)
• Total bilirubin ≤ 1.5 times the upper limit of normal value (ULN) (If there is liver metastasis, allow ≤2.5 times ULN)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN
• Creatinine ≤1.5 times ULN or Creatinine clearance ≥50 mL/min (Calculated according to the Cockcroft Gault formula)
• Serum amylase ≤ 2 times ULN or pancreatic amylase ≤ 1.5 times ULN
• Serum lipase ≤ 1.5 times ULN
• patients who did not take anticoagulants, or those who had previously used anticoagulants, had been discontinued for 28 days before enrollment, and the international normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN.

You may not qualify if:

• The histological component of NSCLC containing small cell lung cancer or squamous cell carcinoma was excluded.
• \. Previously untreated or symptomatic central nervous system (CNS) metastases or meningeal diseases, spinal cord compression, meningeal metastases and brain metastases with obvious symptoms, etc. For those who have received radiotherapy and/or surgery, patients with no evidence of CNS disease progression ≥ 2 weeks after the end of treatment, patients who had not been treated with corticosteroids for more than 2 weeks before the start of treatment were eligible.
• \. Clinically significant hemoptysis (at least 0.5 teaspoons of fresh blood) or tumor bleeding occurred within 2 weeks before the first dose of study treatment.
• \. There is imaging evidence of invasion/infiltration of large vessels. Due to the potential risk of severe bleeding associated with tumor shrinkage/necrosis after apatinib treatment, the degree of tumor invasion/infiltration of major blood vessels should be considered.
• \. Cancerous thrombus with clinical significance, and the use of anticoagulant drugs within 28 days before enrollment.
• \. Clinically uncontrollable pleural effusion/abdominal effusion. 7. Glucocorticoid treatment 28 days before the first dose (equivalent dose of \>10 mg prednisone per day).
• \. Having active autoimmune diseases, which require systemic treatment in the past 2 years (ie using disease-modifying drugs, corticosteroids or immunosuppressive drugs). Replacement therapy (for example, thyroxine, insulin, or physiological corticosteroid replacement therapy due to adrenal or pituitary insufficiency, etc.) is not considered as systemic therapy and is allowed.
• \. History of other malignant tumors in the past 5 years. 10. Has received previous systemic chemotherapy or other targeted or biological anti-tumor treatment for its metastatic NSCLC (As long as treatment is completed at least 6 months before diagnosis of metastatic NSCLC, prior chemotherapy and/or radiotherapy is allowed as part of neoadjuvant/adjuvant therapy for non-metastatic NSCLC).
• \. Previously received anti-PD-1, anti-PD-L1, anti-PD-L2 and other drugs or drugs acting on another stimulatory or co-suppressive T cell receptor (eg CTLA-4, OX 40, CD137 ) therapy, or cell biological therapy, etc.
• \. Previously received treatment with apatinib, or received systemic medication with a clear anti-tumor mechanism.
• \. Allogeneic tissue/solid organ transplantation has been performed. 14. In addition to hair loss and stable peripheral neurotoxicity below grade 2, any clinical toxicity associated with prior treatment before enrollment did not return to pre-treatment levels or grade 1.
• \. pregnancy status (positive blood HCG) and lactation. 16. Previously suffering from interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring hormone therapy, or any active interstitial lung disease with clinical evidence.
• \. Known liver diseases of clinical significance, including active viral hepatitis, alcoholic hepatitis or other hepatitis, liver cirrhosis, hereditary liver disease.( patients who have been cured of previous HBV infection (defined as hepatitis B core antibody \[HBcAb\] positive and HBsAg negative) can participate in this study. Before entering the group, HBV DNA testing must be performed on this class of patients and well-controlled hepatitis B (peripheral HBV DNA testing is less than 103/ml) can be considered for this experiment, and antiviral treatment should be given. Previous patients infected with hepatitis C virus (HCV) had positive HCV antibody test results, They were eligible for this study only if the HCV RNA polymerase chain reaction test result was negative (below the detection limit).) 18. Patients who are suspected or have demonstrated an impaired immune function or infection, including:
• Evidence that active or latent tuberculosis (TB) is determined by locally approved screening methods. If the screening results require treatment in accordance with local treatment guidelines or clinical practice, the patient is disqualified.
• Chronic or active hepatitis B or hepatitis C.

Sponsors & Collaborators

• Hunan Cancer Hospital: lead
• Suzhou Sheng Diya Biomedical Co., Ltd.: collaborator

Study Sites (3)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Location

Hunan Cancer hospital

Changsha, Hunan, China

Location

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

Related Publications (1)

• Pu X, Lin G, Xiao M, Lin J, Wang Q, Kong Y, Yan X, Xu F, Xu Y, Li J, Li K, Chen B, Wen X, Tan Y, Cheng F, Zhu K, Li N, Wu L. Camrelizumab combined with apatinib and nanoparticle albumin-bound paclitaxel in lung adenocarcinoma (CAPAP-lung): a single-arm phase II study. EClinicalMedicine. 2024 Jan 3;67:102403. doi: 10.1016/j.eclinm.2023.102403. eCollection 2024 Jan.

  PMID: 38261958 DERIVED

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

camrelizumab; Immune Checkpoint Inhibitors; apatinib; Angiogenesis Inhibitors

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, director of department

Model Details: Patients fulfilling Eligibility Criteria will be enrolled into our study. Participants are given intravenous administration of Camrelizumab (200mg/3w) in addition with intravenous administration of Albumin Paclitacxel (135mg/m2, d1, d8/3w, 4-6 cycles) and Apatinib (250mg Qd po for 5 days, take rest for 2 days every week). Treatment terminates when disease progression, death or unacceptable toxicity

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 7, 2020
• Study Start: August 26, 2020
• Primary Completion: May 15, 2023
• Study Completion: July 15, 2023
• Last Updated: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: please contact the principal investigator of this study or correspondence author of published work.

Locations

CN (3)