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Squamous NSCLCPhase 2/3NCT07318883

A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung Cancer

A Phase 2/3 study testing HLX07, Serplulimab and Pembrolizumab in people with Squamous NSCLC, run by Shanghai Henlius Biotech at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The study consists of two parts: Part I is a randomized, double-blind, multicenter, parallel-controlled phase II clinical study to evaluate the efficacy and safety of HLX07 in combination with serplulimab and chemotherapy versus placebo in combination with serplulimab and chemotherapy as first-line treatment in… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous NSCLC
What is being tested?
HLX07, Serplulimab and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
720 participants
Where
1 siteChina
Study dates
Mar 2026to Jan 2031
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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

  • The patients voluntarily participate in this clinical study, fully understand and have been informed about the study, have signed the informed consent form (ICF), and are willing to follow and able to complete all study procedures.
  • Male or female, aged 18 years or older at the time of signing the ICF.
  • Histologically confirmed with stage IIIB/IIIC or IV (AJCC 8th edition) squamous NSCLC ineligible for surgery or radical radiotherapy.
  • Patients must provide sufficient tumor tissues that meet the quality requirements for the determination of EGFR and PD-L1 expression levels.
  • Note: Formalin-fixed tumor samples (paraffin blocks or unstained sections, meeting the quality control criteria for testing) collected from lesions that have not received radiotherapy at or after the diagnosis of locally advanced/recurrent or distant metastatic squamous non-small cell lung cancer (sqNSCLC) (from the most recent surgery or biopsy, preferably within half a year prior to randomization) should be provided. Relevant pathology reports must also be provided for the above specimens. For detailed requirements for tissue samples, see the Laboratory Operation Manual.
  • Absence of prior systemic treatment for locally advanced/recurrent or distant metastatic sqNSCLC. Patients who have received prior adjuvant or neoadjuvant therapy are allowed to be enrolled if the adjuvant/neoadjuvant therapy has been completed at least 6 months before the diagnosis of locally advanced/recurrent or distant metastatic sqNSCLC.
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  • Prior non-systemic anti-tumor therapy or Chinese herbal anti-tumor therapy must have ended for ≥ 2 weeks before randomization, and treatment-related AEs have resolved to Grade ≤ 1 according to Common Terminology Criteria for Adverse Events (CTCAE) 6.0 (except for Grade 2 alopecia).
  • At least one measurable target lesion assessed by BICR as per RECIST v1.1 within 4 weeks before randomization.
  • Note: Measurable target lesions cannot be selected from prior radiotherapy sites. A lesion at the prior radiotherapy site may be selected as the target lesion if it is the only available lesion, and should provide the imaging data of the lesion before and after an unequivocal progression after the radiotherapy.
  • An ECOG performance status score of 0 or 1 within 7 days prior to randomization.
  • Life expectancy ≥ 12 weeks.
  • Hepatitis B surface antigen (HBsAg) (-) and hepatitis B core antibody (HBcAb) (-); if HBsAg (+) or HBcAb (+), hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be < 2,500 copies/mL or 500 IU/mL or within the normal range of this site.
  • HCV antibody (-); if HCV antibody (+), HCV-RNA testing must be negative before enrollment. Participants co-infected with hepatitis B and C will be excluded (tested positive for HBsAg or HBcAb and positive for HCV antibody).
  • Adequate major organ functions as defined by the following criteria
  • Female patients must meet one of the following conditions:
  • Post-menopausal (defined as amenorrhea for at least 1 year with no documented cause other than menopause), or
  • Surgically sterilized (removal of the ovaries and/or uterus), or
  • Fertile, but must:
  • be tested negative for serum pregnancy test within 7 days prior to randomization, and
  • agree to use contraception with an annual failure rate of < 1% or to remain abstinent (avoid heterosexual intercourse) from signing the informed consent form to at least 6 months after the last dose of study drugs (contraception with an annual failure rate of < 1% includes bilateral tubal ligation, male sterilization, correct use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper-containing intrauterine devices), and not donate eggs during this period, and
  • not breastfeed.
  • Male patients must: agree to remain abstinent (avoid heterosexual intercourse) or take contraception measures as follows: male patients with a pregnant partner or a partner with childbearing potential must remain abstinent or take contraception measures for contraception during the treatment period with the study drugs and for at least 6 months after the last dose to prevent the drug exposure to the embryo. Periodic abstinence (e.g., contraception based on calendar day, ovulatory phase, basal body temperature, or postovulatory phase) and external ejaculation are ineligible methods of contraception. Sperm donation is prohibited during this period.
  • Patients who have previously received denosumab and are eligible for and agree to switch to bisphosphonates for bone metastases.

Who cannot join

  • Histologically confirmed non-sqNSCLC. Mixed tumors will be classified by the predominant cell type. Patients with small cell component or neuroendocrine carcinoma component are not eligible. For the non-small cell histology, patients with squamous component that is predominant (e.g., adenosquamous) are eligible.
  • Known EGFR-sensitizing mutation, ALK/ROS1 gene rearrangement, or other actionable driver oncogenes for which there are locally approved targeted first-line therapies.
  • Note: If the EGFR, ALK, ROS1 and other actionable driver oncogenes statuses are unknown, testing is not mandatory, unless there are high-risk factors (such as non-smoking female patients), under which circumstances testing of EGFR and other mutations may be considered.
  • Other malignancies within 5 years or active. Patients with localized tumors that have been cured, such as basal cell carcinoma, squamous-cell skin cancer, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, and breast cancer in situ, are eligible.
  • Scheduled or previous organ or bone marrow transplantation.
  • Uncontrollable pleural effusion, pericardial effusion, or ascites.
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  • Active central nervous system (CNS) metastases and/or carcinomatous meningitis known or diagnosed at screening. However, the following patients may be enrolled:
  • Patients with asymptomatic brain metastases (i.e., no progressive central nervous system symptoms caused by brain metastases, no requirement for glucocorticoid therapy, and lesion size ≤ 1.5 cm) may be enrolled, but are required to receive regular brain imaging as a site of lesion.
  • Patients with treated brain metastases that have been stable for at least 1 month, with no evidence of new or enlarging brain metastases, and with glucocorticoid discontinued ≥ 3 days prior to randomization.
  • Stable brain metastases should be confirmed before randomization.
  • Spinal cord compression that has not been cured with radical surgery and/or radiotherapy.
  • Clinically significant hemoptysis complicated with superior vena cava syndrome.
  • Myocardial infarction and poorly controlled arrhythmia (including QTc intervals ≥ 450 ms for males and ≥ 470 ms for females) (QTc intervals are calculated by Fridericia's formula) within 6 months prior to randomization;
  • NYHA Class III-IV cardiac insufficiency or left ventricular ejection fraction (LVEF) < 50% by echocardiography.
  • Inadequately controlled hypertension (defined as systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg), with a history of hypertensive crisis or hypertensive encephalopathy.
  • Grade ≥ 2 peripheral neuropathy as per CTCAE 6.0.
  • Human immunodeficiency virus (HIV) infection.
  • Active pulmonary tuberculosis.
  • A history of or active interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severe lung function impairment that may interfere with the detection and management of suspected drug-related pulmonary toxicity.
  • Known active or suspected autoimmune diseases. Patients with a history of autoimmune disease that does not require systemic immunosuppressive therapy for at least 12 months prior to screening are allowed to be enrolled.
  • Treatment with live vaccines within 28 days prior to randomization. Inactivated seasonal influenza vaccines and COVID-19 vaccines are allowed, but live attenuated influenza vaccines for intranasal use are not allowed.
  • Treatment with systemic glucocorticoids (> 10 mg/day prednisone efficacy dosage) or other immunosuppressive drugs required within 14 days prior to randomization or during the study. However, patients are allowed to be enrolled under the following conditions: in the absence of active autoimmune disease, patients are allowed to use topical or inhaled glucocorticoids and adrenal glucocorticoid replacement therapy at a dose equivalent to ≤ 10 mg/day of prednisone efficacy.
  • Any active infection requiring systemic anti-infective therapy or use of systemic anti-infective therapy within 14 days prior to randomization.
  • Major surgery within 28 days prior to randomization; major surgery in this study is defined as any surgery that requires at least 3 weeks of postoperative recovery time before receiving the study treatment. Patients with a history of tumor needle biopsy or lymph node incisional biopsy are allowed to be enrolled.
  • Radical radiotherapy within 3 months prior to randomization. Note: Palliative radiotherapy to bone or palliative radiotherapy to superficial lesions is allowed according to the local treatment guidelines, which should have been completed 2 weeks prior to randomization. Radiotherapy covering more than 30% of the bone marrow area within 28 days prior to randomization is not allowed.
  • Prior use of other antibodies/drugs against immune checkpoints, such as PD-1, PD-L1, CTLA4, etc. Patients with prior systemic anti-EGFR monoclonal antibody therapy.
  • Current participation in any other clinical study, or the end of the previous clinical study treatment is less than 14 days apart from the planned start of the study treatment in this study.
  • Known history of severe allergy to any monoclonal antibody.
  • Known allergy to any components of carboplatin or paclitaxel (or nab-paclitaxel).
  • Pregnant or lactating women.
  • Known history of psychotropic abuse or drug abuse; history of alcohol abuse.
  • Presence of any other factors that may lead to a premature study discontinuation as judged by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Qinghua Huang contact

+86-021-33395800

Tammy_Huang@henlius.com

China1 site

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Multicenter, Phase II/III Clinical Study to Evaluate HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Patients With Advanced Squamous Non-Small Cell Lung Cancer (sqNSCLC)

The study consists of two parts:

Part I is a randomized, double-blind, multicenter, parallel-controlled phase II clinical study to evaluate the efficacy and safety of HLX07 in combination with serplulimab and chemotherapy versus placebo in combination with serplulimab and chemotherapy as first-line treatment in patients with sqNSCLC.

Part II is a randomized, double-blind, multicenter, parallel-controlled phase III clinical study to evaluate the efficacy and safety of HLX07 in combination with serplulimab and chemotherapy versus placebo in combination with pembrolizumab and chemotherapy as first-line treatment in patients with sqNSCLC.

Conditions
Squamous NSCLC
Being tested
HLX07, HLX07 placebo, Serplulimab, Pembrolizumab, Carboplatin

What participants receive

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

  • HLX07Drug

    Intravenous infusion (IV), once every 3 weeks (Day 1 of each cycle [D1]).

  • HLX07 placeboDrug

    Intravenous infusion (IV), once every 3 weeks (Day 1 of each cycle [D1]).

  • SerplulimabDrug

    Also called HLX10

    IV, once every 3 weeks (D1).

  • PembrolizumabDrug

    Also called Keytruda

    IV, once every 3 weeks (D1).

  • CarboplatinDrug

    IV, once every 3 weeks (D1).

  • Paclitaxel or Nab-PaclitaxelDrug

    Paclitaxel: IV, once every 3 weeks (D1). Nab-paclitaxel: IV, once every 3 weeks (D1, 8, 15).

Study groups in NCT07318883
Study groupRoleWhat they receive
Part I (phase 2)-Group AExperimentalHLX07 + serplulimab + carboplatin + paclitaxel or nab-paclitaxel, once every 3 weeks for a total of 4 cycles, followed by maintenance therapy with HLX07 in combination with serplulimab, with serplulimab administered for up to 2 years.
Receives: Drug: HLX07; Drug: Serplulimab; Drug: Carboplatin; Drug: Paclitaxel or Nab-Paclitaxel
Part I (phase 2)-Group BActive comparatorPlacebo + serplulimab + carboplatin + paclitaxel or nab-paclitaxel, once every 3 weeks for a total of 4 cycles, followed by maintenance therapy with placebo in combination with serplulimab, with serplulimab administered for up to 2 years.
Receives: Drug: HLX07 placebo; Drug: Serplulimab; Drug: Carboplatin; Drug: Paclitaxel or Nab-Paclitaxel
Part II (phase 3)-Group AExperimentalHLX07 + serplulimab + carboplatin + paclitaxel or nab-paclitaxel, once every 3 weeks for a total of 4 cycles, followed by maintenance therapy with HLX07 in combination with serplulimab, with serplulimab administered for up to 2 years.
Receives: Drug: HLX07; Drug: Serplulimab; Drug: Carboplatin; Drug: Paclitaxel or Nab-Paclitaxel
Part II (phase 3)-Group BActive comparatorPlacebo + pembrolizumab + carboplatin + paclitaxel or nab-paclitaxel, once every 3 weeks for a total of 4 cycles, followed by maintenance therapy with placebo in combination with pembrolizumab, with pembrolizumab administered for up to 2 years.
Receives: Drug: HLX07 placebo; Drug: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel or Nab-Paclitaxel

What is being measured

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

  1. ORR assessed by BICR (part I)

    Defined as the proportion of participants who achieve a best overall response of CR or PR

    Measured: Assessed up to appoximately 6 months from enrollment

  2. PFS assessed by BICR (part I)

    Defined as the time from randomization to the first documentation of PD (RECIST v1.1) or death due to any cause (whichever occurs first)

    Measured: Assessed up to appoximately 16 months from enrollment

  3. PFS assessed by BICR (part II)

    Defined as the time from randomization to the first documentation of PD (RECIST v1.1) or death due to any cause (whichever occurs first)

    Measured: Assessed up to appoximately 23 months from enrollment

  4. OS (part II)

    Defined as the time from randomization to death due to any cause

    Measured: Assessed up to appoximately 42 months from enrollment

Secondary outcomes (11)

  1. DCR (part I)

    Defined as the proportion of participants who achieve a best overall response of CR or PR or an SD

    Measured: Assessed up to appoximately 6 months from enrollment

  2. OS (part I)

    Defined as the time from randomization to death due to any cause

    Measured: Assessed up to appoximately 35 months from enrollment

  3. DOR (part I)

    Defined as the time from the first documented objective response to PD or death

    Measured: Assessed up to appoximately 35 months from enrollment

  4. ORR assessed by investigator (part I)

    Defined as the proportion of participants who achieve a best overall response of CR or PR

    Measured: Assessed up to appoximately 6 months from enrollment

  5. PFS assessed by investigator (part I)

    Defined as the time from randomization to the first documentation of PD (RECIST v1.1) or death due to any cause (whichever occurs first)

    Measured: Assessed up to appoximately 16 months from enrollment

  6. Incidence of adverse events (part I)

    Measured: Assessed up to appoximately 35 months from enrollment

  7. ORR (part II)

    Defined as the proportion of participants who achieve a best overall response of CR or PR

    Measured: Assessed up to appoximately 6 months from enrollment

  8. DCR (part II)

    defined as the proportion of participants who achieve a best overall response of CR or PR or an SD lasting for 12 weeks

    Measured: Assessed up to appoximately 6 months from enrollment

  9. DOR (part II)

    Defined as the time from the first documented objective response to PD or death

    Measured: Assessed up to appoximately 42 months from enrollment

  10. PFS assessed by investigator (part II)

    Defined as the time from randomization to the first documentation of PD (RECIST v1.1) or death due to any cause (whichever occurs first)

    Measured: Assessed up to appoximately 23 months from enrollment

  11. Incidence of adverse events (part II)

    Measured: Assessed up to appoximately 42 months from enrollment

Timeline

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

  1. First posted6 Jan 2026
  2. Study startMar 2026 (estimated)
  3. Primary completionJan 2031 (estimated)
  4. Study completionJan 2031 (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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
720 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07318883
Sponsor's protocol ID
HLX07-sqNSCLC301
Status last verified
Jan 2026
First submitted
4 Jan 2026
Last updated
6 Jan 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing HLX07, Serplulimab and Pembrolizumab in people with Squamous NSCLC, run by Shanghai Henlius Biotech at 1 site 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 23 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: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Qinghua Huang (+86-021-33395800, Tammy_Huang@henlius.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR assessed by BICR (part I) (time frame: Assessed up to appoximately 6 months from enrollment). The study lists 4 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 NCT07318883.

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 6 Jan 2026.

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