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Nonsquamous Non-small Cell Lung CancerPhase 2/3NCT04750083

HX008 Plus Chemotherapy VS Pembrolizumab Plus Chemotherapy As the First-line Treatment in Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer

A Phase 2/3 study testing HX008, Pembrolizumab and pemetrexed in people with Nonsquamous Non-small Cell Lung Cancer, run by Taizhou Hanzhong biomedical co. LTD at 10 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

This a phase II-III study. In the single-armed phase II period, HX008, a monoclonal antibody targeting PD-1, will be combined with pemetrexed+platinum (Investigators choice of cisplatin or carboplatin) chemotherapy to treat participants with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nonsquamous Non-small Cell Lung Cancer
What is being tested?
HX008, Pembrolizumab and pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
10 sitesChina
Study dates
25 Sep 2020to 25 Sep 2023
Phase
Phase 2/3
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

  • Understood and signed an informed consent form.
  • Age ≥ 18 years old, male or female.
  • Have a histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b- AJCC 7th edition) nonsquamous NSCLC.
  • Have not received prior systemic treatment for their advanced/metastatic NSCLC. Subjects who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease.
  • Have confirmation that EGFR or ALK-directed therapy is not indicated.
  • Have at least one measurable lesion according to RECIST1.1. Lesions situated in previously irradiated areas could be considered as target lesions if progression has been demonstrated in such lesions. If measurable lesions exist in other areas, lesions in previous irradiated areas should be considered as non-target lesions.
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  • Have provided tumor tissue from locations not radiated prior to biopsy for determination of PD-L1 status prior to randomization. Formalin fixed specimens the subject has been diagnosed with metastatic disease will be preferred. Biopsies obtained prior to receipt of adjuvant/neoadjuvant chemotherapy will be permitted if recent biopsy is not feasible.
  • Life expectancy ≥ 3 months.
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score.
  • Have adequate organ function as indicated by the following laboratory values:
  • Blood routine: serum albumin ≥2.5g/dL; absolute neutrophil count (ANC) ≥1.5×10^9/L; while blood cell count (WBC) ≥3×10^9/L; platelet count (PLT) ≥100×10^9/L; hemoglobin (HGB) ≥90 g/L (without blood transfusion within 4 weeks prior to enrollment);
  • Renal function: creatinine clearance (CrCl) ≥50 mL/min;
  • Liver function: Patients without liver metastases require alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN. Patients with liver metastases require: ALT and AST≤5×ULN. Serum total bilirubin ≤1.5xULN or direct bilirubin ≤ULN for subjects with total bilirubin levels >1.5xULN;
  • International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy; OR activated Partial Thromboplastin Time (aPTT) or Partial Thromboplastin Time (PTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy.
  • If female of childbearing potential, have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • If female of childbearing potential, be willing to use an adequate method of contraception as outlined in Section 4.3-Contraception, for the course of the study through 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents as specified in the protocol. If male subject with a female partner(s) of child-bearing potential, must agree to use an adequate method of contraception as outlined in Section 4.3-Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy or through 180 days after last dose of chemotherapeutic agents as specified in the protocol. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
  • Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

Who cannot join

  • The subject must be excluded from participating in the trial if the subject:
  • Has predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the subject is ineligible.
  • Before the first dose of trial treatment:
  • Has received prior systemic cytotoxic chemotherapy or other antineoplastic therapy (e.g., erlotinib, crizotinib, cetuximab) for metastatic disease
  • Had major surgery within 3 weeks prior to the first dose of trial treatment
  • Has participated in other clinical trial within 4 weeks prior to the first dose
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  • Received radiation therapy to the lung that is > 30 Gy within 6 months prior to the first dose
  • Completed palliative radiotherapy within 7 days prior to the first dose
  • Has received a live-virus vaccination within 30 days prior to the first dose. Seasonal flu vaccines that do not contain live virus are permitted.
  • Has clinically active diverticulitis, intra-abdominal abscess, GI obstruction, peritoneal carcinomatosis.
  • Suffered from other malignant tumors in the past 5 years, except those with low risk of metastasis and death (5-year survival rate > 90%), for instance, skin basal cell carcinoma, squamous cell carcinoma, and carcinoma in situ from cervix or other regions that have been adequately treated.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks and, have no evidence of new or enlarging brain metastases and also are off steroids 3 days prior to dosing with study medication. Stable brain metastases by this definition should be established prior to the first dose of study medication. Subjects with known untreated, asymptomatic brain metastases (ie, no neurological symptoms, no requirements for corticosteroids, no or minimal surrounding edema, and no lesion >1.5 cm) may participate but will require regular imaging of the brain as a site of disease.
  • Has a known sensitivity to macromolecular agents or any component of cisplatin, carboplatin or pemetrexed.
  • Has a history of organ or stem-cell transplantation.
  • Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Has received systemic corticosteroids (a calculated dose >10mg prednisone per day ) or other immunosuppressive drugs within 14 days before the first administration of the study drug, excluding:
  • Nasal spray, inhalation or other local glucocorticoids.
  • Short-term (≤ 7 days) use of glucocorticoids as a preventive medication for allergic reactions or as a therapeutic medication for non-autoimmune diseases.
  • Is on chronic systemic steroids. Subjects with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study.
  • Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤ 1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
  • Is unable or unwilling to take folic acid or vitamin B12 supplementation.
  • Had prior treatment with any anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms. Examples of such antibodies include (but are not limited to) antibodies against IDO, PD-L1, IL-2R, GITR.
  • Has a severe active infection prior to the first administration of the study drug and might not in the best interest of the subject to participate, in the opinion of the Investigator.
  • Has known history of Human Immunodeficiency Virus (HIV) (known HIV 1/2 antibodies positive).
  • Has known active Hepatitis B or C. Active Hepatitis B is defined as a known positive HBsAg result. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay. Those with HBV DNA viral load or copy number lower than the lower limits of detection of the assay or HCV RNA negative after adequate treatment is eligible.
  • Has known psychiatric or mental disorders, such as epilepsy, dementia, or a known regular user of any illicit drugs, or had a recent history (within the last year) of substance abuse (including alcohol) that would interfere with cooperation with the requirements of the trial.
  • Has symptomatic ascites or pleural effusion. A subject who is clinically stable following treatment for these conditions (including therapeutic paracentesis) is eligible.
  • Has a history of non-infectious pneumonitis that required steroids or active interstitial pneumonia. Other moderate and severe lung diseases that may interfere with the detection or treatment of study drug-related pulmonary toxicity or seriously affect respiratory function, such as idiopathic pulmonary fibrosis, organic pneumonia / bronchiolitis obliterans, etc (except for local pneumonia induced by radiotherapy).
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
  • Has active tuberculosis.
  • Has uncontrolled systemic diseases, for instance, cardiovascular and cerebrovascular disease, diabetes, hypertension, etc.
  • Has a history or current evidence of any condition, or laboratory abnormality that might not in the best interest of the subject to participate, in the opinion of the Investigator.

Trial locations and contacts

10 sites in 1 country.

Caicun Zhou, MD contact

021-65115006 ext. 3051

caicunzhoudr@163.com

10 sites in 1 country

China10 sites, 10 recruiting

  • Beijing Chaoyang Hospital ,Capital Medical University

    Beijing, Beijing Municipality, 100020

    Yang Ge, MD, interna-1@163.com

    Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Jian Fang, fangjian5555@yeah.net

    Recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

    Baoshan Cao, MD, caobaoshan0711@aliyun.com

    Recruiting

  • Hunan Province Cancer Hospital

    Changsha, Hunan, 410000

    Lin Wu, MD, wulin-calf@vip.163.com

    Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410000

    Pinhua Pan, MD, Pinhuapan668@126.com

    Recruiting

  • Affiliated Hangzhou Cancer Hospital

    Hangzhou, Zhejiang, 310002

    Xueqin Chen, MD, chenlucy1437@aliyun.com

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

    Yan Yu, MD, gpyuyan@163.com

    Recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

    Lejie Cao, Master's degree (Medicine), sycaolejie@163.com

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

    Caicun Zhou, MD, 02165115006 ext. 3051, caicunzhoudr@163.com

    Recruiting

  • Liaoning Cancer Hospital & Insititute

    Shenyang, Liaoning, 110042

    Xiaoling Li, MD, lxlingsy@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase II/III Study Comparing HX008 (a Humanized Monoclonal Antibody Against PD-1) Plus Chemotherapy With Pembrolizumab Plus Chemotherapy as the First-line Treatment in Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer.

This a phase II-III study. In the single-armed phase II period, HX008, a monoclonal antibody targeting PD-1, will be combined with pemetrexed+platinum (Investigators choice of cisplatin or carboplatin) chemotherapy to treat participants with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease. When the preliminary efficacy and safety data are acquired, a single-blinded phase III study will ensue, in which the efficacy and safety of HX008+pemetrexed+platinum VS pembrolizumab+pemetrexed+platinum in participants of the same population will be compared head-to-head with 1:1 randomization. The primary endpoints are safety and ORR (overall response rate) evaluated by the investigator in phase II study, and PFS evaluated by IRC (independent review committee) in phase III study. The primary hypothesis in phase III study is that HX008+pemetrexed+platinum is non-inferior to pembrolizumab+pemetrexed+platinum in terms of PFS (Progression-Free Survival).

Being tested
HX008, Pembrolizumab, pemetrexed, cisplatin/carboplatin

What participants receive

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

  • HX008Drug

    HX008 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to 35 cycles

  • PembrolizumabDrug

    Pembrolizumab 200 mg intravenously (IV) on Day 1 of Q3W for up to 35 cycles

  • pemetrexedDrug

    pemetrexed 500 mg/m^2 IV on Day 1 of Q3W for up to 35 cycles

  • cisplatin/carboplatinDrug

    cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of Q3W for 4 cycles

Study groups in NCT04750083
Study groupRoleWhat they receive
phase IIExperimentalThirty-sixty participants will receive HX008 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m^2 IV PLUS cisplatin 75 mg/m^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W for another 31 cycles.
Receives: Drug: HX008; Drug: pemetrexed; Drug: cisplatin/carboplatin
phase III-experimentalExperimentalThree hundred and twenty participants will receive HX008 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m^2 IV PLUS cisplatin 75 mg/m^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W for another 31 cycles.
Receives: Drug: HX008; Drug: pemetrexed; Drug: cisplatin/carboplatin
phase III-controlExperimentalThree hundred and twenty participants will receive pembrolizumab 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m^2 IV PLUS cisplatin 75 mg/m^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W for another 31 cycles.
Receives: Drug: Pembrolizumab; Drug: pemetrexed; Drug: cisplatin/carboplatin

What is being measured

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

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 in phase II study

    Measured: 12 months

  2. Objective Response Rate (ORR) in phase II study

    Percentage of subjects achieving complete response (CR) and partial response (PR)

    Measured: 12 months

  3. Progression-Free Survival (PFS) in phase III study

    The time from the first study drug treatment to disease progression (PD) or to death of the subject due to any reason.

    Measured: 24 months

Secondary outcomes (6)

  1. Objective Response Rate (ORR) in phase III study

    The time from the first study drug treatment to disease progression (PD) or to death of the subject due to any reason.

    Measured: 24 months

  2. Progression-Free Survival (PFS) in phase II study

    The time from the first study drug treatment to disease progression (PD) or to death of the subject due to any reason.

    Measured: 24 months

  3. Duration of Response (DOR) in phase II and III study

    Duration of Response (DOR) is defined as the time from the first evidence of response (PR or CR) to the first evidence of PD or the date of death for any reason.

    Measured: 24 months

  4. 12-month PFS rate in phase II and III study

    The rate of participants who experienced neither disease progression (PD) nor death due to any reason in one year after the first study drug treatment.

    Measured: 24 months

  5. Overall survival (OS) in phase II and III study

    Overall survival (OS) refers to the time from the first study drug treatment to death due to any cause.

    Measured: 36 months

  6. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 in phase III study

    Evaluating the safety and tolerance of HX008+pemetrexed+platinum as the first-line treatment in the participants with advanced or metastatic nonsquamous NSCLC.

    Measured: 36 months

Timeline

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

  1. First posted11 Feb 2021
  2. Study start25 Sep 2020
  3. Primary completion25 Sep 2022 (estimated)
  4. Study completion25 Sep 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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04750083
Sponsor's protocol ID
HX008-NSCLC-II/III-01
Status last verified
Feb 2021
First submitted
3 Feb 2021
Last updated
11 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing HX008, Pembrolizumab and pemetrexed in people with Nonsquamous Non-small Cell Lung Cancer, run by Taizhou Hanzhong biomedical co. LTD at 10 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 17 inclusion and 32 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 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Caicun Zhou, MD (021-65115006 ext. 3051, caicunzhoudr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 in phase II study (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT04750083.

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 11 Feb 2021.

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