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

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Brief Title

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

Official Title

A Prospective Single-arm Phase II Clinical Study to Evaluate the Efficacy of Camrelizumab in Combined With APatinib and Albumin Paclitacxel in Advanced Untreated EGFR Wild Type and ALK-negative Lung Adenocarcinoma

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.
    

Detailed Description

      Primary outcome:

      1. progression free survival (PFS) evaluated according to RECIST1.1.

      Secondary outcome:

        1. Objective Response Rate (ORR), Overall Survival (OS), Disease Control Rate (DCR),
           Duration of Response (DOR) evaluated according to RECIST1.1, and Quality of Life(QOL).

        2. The overall incidence of adverse events (AE); the incidence of grade 3 or above AE; the
           incidence of serious adverse events (SAE); the incidence of AE leading to the
           termination of the trial drug; the incidence of AE leading to the suspension of the
           trial drug.

        3. Exploratory research: PFS, ORR, DOR, DCR evaluated according to iRECIST.

        4. Exploratory analysis of potential biomarkers related to efficacy. The characteristics of
           tumor tissue PD-L1expression, panel-captured next generation sequencing(NGS), RNA-seq,
           T-Cell Repertoire (TCR), multiple immunofluorescence and other biomarkers, and the
           correlation analysis of biomarkers with efficacy and safety.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

PFS

Secondary Outcome

 ORR

Condition

Adenocarcinoma of the Lung

Intervention

Camrelizumab

Study Arms / Comparison Groups

 Camrelizumab combined with Albumin Paclitacxel and Apatinib.
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

63

Start Date

July 15, 2020

Completion Date

July 15, 2023

Primary Completion Date

July 15, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  1. Age 18-70 years, both men and women can be enrolled 2. Histologically confirmed
             adenocarcinoma (large cell neuroendocrine carcinoma, adenosquamous carcinoma and other
             rare pathological types are excluded), and does not contain small cell components.

             3. 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 .

             4. ECOG score of physical condition was 0-1, and there was no deterioration in the
             first 2 weeks. Expected survival over 12 weeks.

             5. 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.

             6. Laboratory certified by CAP reported negative in EGFR and ALK mutation-sensitive
             mutations.

             7. Clinical laboratory examination indicators meet the following standards:

               1. Platelet ≥100×109/L

               2. Absolute neutrophil count (ANC) ≥1.5×109/L, or absolute white blood cell count
                  (WBC) ≥3.5×109/L

               3. Hemoglobin (Hgb) ≥ 100 g/L (without blood transfusion or erythropoietin use
                  within 4 weeks)

               4. Total bilirubin ≤ 1.5 times the upper limit of normal value (ULN) (If there is
                  liver metastasis, allow ≤2.5 times ULN)

               5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times
                  ULN

               6. Creatinine ≤1.5 times ULN or Creatinine clearance ≥50 mL/min (Calculated
                  according to the Cockcroft Gault formula)

               7. Serum amylase ≤ 2 times ULN or pancreatic amylase ≤ 1.5 times ULN

               8. Serum lipase ≤ 1.5 times ULN

               9. 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.

                  8. Able to swallow oral medication. 9. Enough tissue specimens for PD-L1
                  detection or exploratory analysis.

                  Exclusion Criteria:

          -  1. Exclude patients whose tumor components contain small cell lung cancer,
             neuroendocrine cancer, sarcoma, etc., or mixed pathological components.

             2. 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.

             3. 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.

             4. 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.

             5. Cancerous thrombus with clinical significance, and the use of anticoagulant drugs
             within 28 days before enrollment.

             6. Clinically uncontrollable pleural effusion/abdominal effusion. 7. Glucocorticoid
             treatment 28 days before the first dose (equivalent dose of >10 mg prednisone per
             day).

             8. 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.

             9. 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).

             11. 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.

             12. Previously received treatment with apatinib, or received systemic medication with
             a clear anti-tumor mechanism.

             13. 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.

             15. 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.

             17. 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.

               -  Known history of human immunodeficiency virus (HIV) infection. During the
                  screening period, the local test result was positive.

               -  There are any other medical conditions (such as active infections that have been
                  treated or not treated) that the investigator believes that the patient has an
                  unacceptable risk if receiving immunomodulatory therapy(Patients with local
                  diseases that are unlikely to cause systemic infections (such as chronic nail
                  fungal infections) are allowed to be enrolled).

                  19. Allogeneic bone marrow or organ transplantation. 20. Any immunomodulator with
                  systemic effects. 21. Known mental illness or substance abuse disorders that
                  interfere with a subject's ability to comply with research requirements.

                  22. Previous severe allergy to mAb treatment or known allergy or intolerance to
                  any component of study medication (apatinib, caririzumab).
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

, +8613170419973, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04459078

Organization ID

CAPAP-lung


Responsible Party

Principal Investigator

Study Sponsor

Hunan Cancer Hospital

Collaborators

 Suzhou Sheng Diya Biomedical Co., Ltd.

Study Sponsor

, , 


Verification Date

July 2020