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Adenocarcinoma of the LungPhase 2NCT04459078

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

A Phase 2 study testing Camrelizumab, Albumin Paclitacxel and Apatinib in people with Adenocarcinoma of the Lung, run by Hunan Cancer Hospital at 3 sites in China.

Unknown status

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 The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adenocarcinoma of the Lung
What is being tested?
Camrelizumab, Albumin Paclitacxel and Apatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
3 sitesChina
Study dates
26 Aug 2020to 15 Jul 2023
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Age>=18 years, both men and women can be enrolled 2. Histologically confirmed adenocarcinoma (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:
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  • 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.
  • 8. Able to swallow oral medication. 9. Enough tissue specimens for PD-L1 detection or exploratory analysis.

Who cannot join

  • 1.The histological component of NSCLC containing small cell lung cancer or squamous cell carcinoma was excluded.
  • 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).
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  • 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).

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Hunan Cancer hospital

    Changsha, Hunan

  • Fujian Cancer Hospital

    Fuzhou, Fujian

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

Other trials in China

About this study

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

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.

Read the 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 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.
Being tested
Camrelizumab, Albumin Paclitacxel, Apatinib
Keywords
immunotherapy, PD-1 checkpoint inhibitor, Anti-angiogenesis, First-line Treatment
Medical subject headings
Adenocarcinoma of Lung

What participants receive

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

  • CamrelizumabDrug

    Also called SHR1210, PD-1 inhibitor

    Intravenous administration of (200mg/3weeks)

  • Albumin PaclitacxelDrug

    Also called Chemotherapy drug

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

  • ApatinibDrug

    Also called Anti-angiogenesis drug

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

Study groups in NCT04459078
Study groupRoleWhat they receive
Camrelizumab combined with Albumin Paclitacxel and Apatinib.ExperimentalParticipants 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.
Receives: Drug: Camrelizumab; Drug: Albumin Paclitacxel; Drug: Apatinib

What is being measured

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

  1. PFS

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

    Measured: Up to 24 months

Secondary outcomes (6)

  1. ORR

    Objective Remission Rate (ORR) evaluated by researchers based on the RECIST 1.1 criteria.

    Measured: Up to 24 months

  2. OS

    Overall Survival (OS) evaluated by researchers based on the RECIST 1.1 criteria.

    Measured: Up to 24 months

  3. DCR

    Disease Control Rate（DCR）evaluated by researchers based on the RECIST 1.1 criteria.

    Measured: Up to 24 months

  4. DOR

    Duration of Response (DOR) evaluated by researchers based on the RECIST 1.1 criteria.

    Measured: Up to 24 months

  5. The change of quality of life

    The change of quality of life is measured using the European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnaire（EORTC QLQ）

    Measured: Up to 24 months

  6. AE

    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

    Measured: Up to 24 months

Timeline

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

  1. First posted7 Jul 2020
  2. Study start26 Aug 2020
  3. Primary completion15 May 2023 (estimated)
  4. Study completion15 Jul 2023 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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
Masking
None (open label)
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04459078
Sponsor's protocol ID
CAPAP-lung
Status last verified
Nov 2022
First submitted
29 Jun 2020
Last updated
2 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Publications

  • 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.

    PubMed 38261958

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab, Albumin Paclitacxel and Apatinib in people with Adenocarcinoma of the Lung, run by Hunan Cancer Hospital at 3 sites in China.

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 16 inclusion and 19 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 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: Up to 24 months). 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 NCT04459078, which also lists 1 linked publication.

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 2 Dec 2022.

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