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NSCLC (Advanced Non-small Cell Lung Cancer)Phase 2PRAD2NCT07627321

Becotatug Vedotin Combined With Pucotenlimab ± Radiotherapy as First-Line Treatment for Driver-Gene-Negative, EGFR-Expression-Positive Advanced Non-Small Cell Lung Cancer

A Phase 2 study testing Pucotenlimab, Becotatug vedotin and Radiotherapy in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Anhui Provincial Cancer Hospital 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

This prospective, single-arm, exploratory multicenter clinical study aims to investigate the safety and efficacy of Becotatug vedotin combined with Pucotenlimab (with or without radiotherapy), followed by Pucotenlimab maintenance therapy, in patients with driver gene-negative (e.g., EGFR, ALK, ROS1)… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Pucotenlimab, Becotatug vedotin and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteChina
Study dates
15 Jul 2026to 16 Jul 2029
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary participation with written informed consent obtained prior to any study-specific procedures, and willingness to comply with the study requirements.
  • Male or female patients aged between 18 and 75 years (inclusive) at the time of signing informed consent.
  • Histologically or cytologically confirmed Stage IV (M1a, M1b, or M1c according to the AJCC 8th Edition) squamous or non-squamous NSCLC.
  • No prior systemic therapy for advanced/metastatic disease is permitted. Patients who received adjuvant/neoadjuvant chemotherapy and relapsed ≥6 months after the last dose are allowed to enroll.
  • At baseline, presence of at least one measurable target lesion outside the primary tumor per RECIST v1.1, which is suitable for accurate repeated measurement and has not been previously irradiated or treated with other local therapies.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
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  • Absence of known actionable driver gene alterations (e.g., EGFR, ALK, ROS1) in both squamous and non-squamous NSCLC. All subjects (regardless of smoking history) must provide testing reports for EGFR, ALK, and ROS1. If no prior report exists, baseline biopsy or submission of archived tissue for assessment of driver gene status (via local or central laboratory) is mandatory.
  • Immunohistochemistry (IHC)-confirmed EGFR expression level of 2+ or higher.
  • Medically fit to tolerate radiotherapy, with an expected survival of ≥12 weeks.
  • No prior exposure to Antibody-Drug Conjugates (ADCs).
  • Adequate organ and bone marrow function as defined below (within 14 days prior to initiation of study treatment):
  • Hematology (must not have received blood transfusions, granulocyte colony-stimulating factor [G-CSF], or hematopoietic growth factors within 14 days prior to screening):
  • Hemoglobin (Hb) ≥ 90 g/L;
  • Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L;
  • Platelets (PLT) ≥ 75 × 10⁹/L.
  • Blood Chemistry (must not have received albumin infusion within 14 days prior to screening):
  • Total Bilirubin (TBIL) ≤ 2.0 × ULN (≤ 3.0 × ULN for patients with Gilbert's syndrome);
  • Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 5.0 × ULN;
  • Serum Creatinine (Cr) ≤ 1.5 × ULN or Calculated Creatinine Clearance (CrCl) ≥ 50 mL/min (using the Cockcroft-Gault formula):
  • Male: CrCl = ((140 - age) × weight) / (72 × serum creatinine) Female: CrCl = ((140 - age) × weight) / (72 × serum creatinine) × 0.85 (Note: Weight in kg; Serum creatinine in mg/dL)
  • Coagulation Function:
  • International Normalized Ratio (INR) ≤ 2.0 or Prothrombin Time (PT) ≤ 6 seconds above the upper limit of normal.
  • Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the first dose. If the urine test cannot be definitively confirmed as negative, a serum pregnancy test must be performed, and the serum result will be considered definitive.
  • Female subjects of childbearing potential who are sexually active with unsterilized male partners must agree to use highly effective contraception starting at screening and continue for 180 days after the last dose of study drug.
  • Sexually active male subjects who have not undergone sterilization and who are sexually active with female partners of childbearing potential must agree to use effective contraception starting at screening and continue for 180 days after the last dose. Decisions regarding the cessation of contraception beyond this timeframe should be discussed with the investigator.
  • Subjects must be willing and able to comply with scheduled visits, the treatment plan, laboratory tests, and other study requirements.

Who cannot join

  • 1. Prior receipt of any systemic anti-tumor therapy for advanced, recurrent, or metastatic NSCLC, or perioperative therapy completed less than 6 months prior to enrollment.
  • 2. History of another malignancy within 5 years prior to enrollment (excluding cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
  • Known hypersensitivity to Becotatug vedotin, Pucotenlimab, or any of their excipients.
  • 3. Prior treatment with any of the following: ADCs, PD-1/PD-L1 inhibitors, CTLA-4 inhibitors, or bispecific antibodies targeting immune checkpoints.
  • 5. History of severe bleeding tendency or coagulation dysfunction; significant clinically significant bleeding symptoms within 1 month prior to the first dose (including but not limited to gastrointestinal bleeding, hemoptysis [defined as expectoration of ≥1 teaspoon of fresh blood or blood clots, or pure hemoptysis without sputum; subjects with blood-streaked sputum are allowed]); nasal hemorrhage (excluding simple epistaxis and post-nasal drip with blood); imaging at screening showing tumor encasement of major vessels, significant tumor necrosis, or cavitation deemed by the investigator to pose a high bleeding risk; central or cavitary squamous NSCLC deemed high-risk for bleeding by the investigator; receipt of continuous antiplatelet or anticoagulant therapy within 10 days prior to the first dose.
  • 6. Tumor invasion of surrounding vital organs or vessels (e.g., aorta, heart and pericardium, superior vena cava, trachea, esophagus) or presence of risk factors for esophagotracheal fistula or esophagopleural fistula.
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  • 7. Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (subjects not requiring drainage or requiring drainage less than once per month are allowed).
  • 8. Arteriovenous thromboembolic events within 6 months prior to randomization, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except those judged by the investigator to be fully resolved and related to venous catheters for prior chemotherapy), and pulmonary embolism.
  • 9. Symptomatic brain metastases. Subjects with brain metastases that have been treated and remain clinically stable for at least 1 month, and who have discontinued corticosteroids and anticonvulsants for at least 1 month prior to study entry, are allowed.
  • 10. Inability to provide documentation of driver gene-negative status or IHC evidence confirming EGFR expression ≥2+.
  • Comorbidities/Medical History:
  • 11. Hypertension that cannot be adequately controlled with antihypertensive medication (systolic BP >140 mmHg or diastolic BP >90 mmHg);
  • Within 6 months prior to randomization: myocardial infarction, severe/unstable angina, NYHA Class II or greater cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure;
  • Conditions significantly affecting oral drug absorption, such as inability to swallow, chronic diarrhea, or clinically significant intestinal obstruction;
  • Renal insufficiency: urinalysis indicating proteinuria ≥++, or confirmed 24-hour urine protein ≥1.0 g;
  • Human Immunodeficiency Virus (HIV) infection or known Acquired Immunodeficiency Syndrome (AIDS); active hepatitis (Hepatitis B defined as HBV-DNA ≥ 500 IU/mL; Hepatitis C defined as HCV-RNA above the lower limit of detection) or co-infection with Hepatitis B and C;
  • Presence of any active autoimmune disease or history thereof (including but not limited to autoimmune hepatitis, enteritis, vasculitis, nephritis; subjects requiring bronchodilator therapy for asthma are excluded); however, subjects with vitiligo, psoriasis, alopecia not requiring systemic treatment, or well-controlled Type 1 diabetes are allowed;
  • Severe infection within 4 weeks prior to the first dose, including but not limited to bacteremia or severe pneumonia requiring hospitalization; active infection requiring systemic antibiotics within 2 weeks prior to the first dose (CTCAE Grade ≥2); fever >38.5°C of unknown origin during screening/prior to first dose (fever due to tumor progression judged by the investigator is allowed); evidence of active tuberculosis infection within 1 year prior to dosing.
  • 12. Major surgery within 28 days prior to the first dose (diagnostic tissue biopsy, PICC line placement, or PORT placement are allowed).
  • 13. Prior allogeneic bone marrow transplantation or solid organ transplantation.
  • 14. History of substance abuse or psychiatric disorders that cannot be controlled or withdrawn.
  • 15. History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, organ transplantation, or allogeneic bone marrow transplantation.
  • 16. Currently participating in another interventional clinical study, unless it is an observational (non-interventional) study or the follow-up phase of an interventional study.
  • 17. Pregnant or lactating women. 18. Any other condition that, in the investigator's judgment, would compromise the subject's safety, hinder compliance, or necessitate premature study termination (e.g., severe concomitant illness, alcoholism, drug abuse, or social/familial circumstances).

Trial locations and contacts

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

ShangHu Yuan, MD contact

86+ 13853106916

yuanshuanghu@sina.com

China1 site

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230031

    ShangHu Yuan, MD, 86+ 13853106916, yuanshuanghu@sina.com这就是袁的邮箱吧

Other trials in China

About this study

Official title: PRAD2: A Prospective, Single-Arm, Multi-Center, Exploratory Study of Becotatug Vedotin Combined With Pucotenlimab ± Radiotherapy as First-Line Treatment for Driver-Gene-Negative, EGFR-Expression-Positive Advanced Non-Small Cell Lung Cancer

This prospective, single-arm, exploratory multicenter clinical study aims to investigate the safety and efficacy of Becotatug vedotin combined with Pucotenlimab (with or without radiotherapy), followed by Pucotenlimab maintenance therapy, in patients with driver gene-negative (e.g., EGFR, ALK, ROS1), EGFR-overexpressing non-small cell lung cancer (NSCLC).

Study Population:

Read more

The study targets patients with driver gene-negative (EGFR, ALK, ROS1, and other actionable targets) non-squamous and squamous NSCLC. All subjects (regardless of smoking history) must provide testing reports for EGFR, ALK, and ROS1. If no prior report exists, baseline biopsy or submission of archived tissue for assessment of driver gene status (via local or central laboratory) is mandatory. Additionally, eligible patients must have an immunohistochemistry (IHC)-confirmed EGFR expression level of 2+ or higher, be previously untreated with systemic therapy for stage IV NSCLC, have measurable lesions, show no active central nervous system metastases or uncontrolled autoimmune diseases, and voluntarily sign the informed consent form.

Treatment Regimen:

Subjects meeting the inclusion/exclusion criteria will receive the following treatment regimen:

Pucotenlimab (HX008): Administered from Cycle 1 to Cycle 4 at a dose of 3 mg/kg (maximum 200 mg), once every 3 weeks on Day 1 (D1). Intravenous infusion (60 ± 15 minutes; first cycle infusion duration not less than 60 minutes).

Becotatug vedotin (MRG003): Administered from Cycle 1 to Cycle 4 at a dose of 2.0 mg/kg, once every 3 weeks on D1. Administration begins at least 30 minutes after the completion of Pucotenlimab infusion. Intravenous infusion (60 ± 10 minutes; first cycle infusion duration not less than 60 minutes).

Radiotherapy: Investigators may opt to include sequential radiotherapy based on tumor size, number, location, extent of invasion, and individual patient factors. Radiotherapy options are as follows:

Target Volume: Radiotherapy commences 2 weeks (±7 days) after the completion of Cycle 4 treatment, targeting only the primary tumor or specific 1-2 metastatic lesions.

Fractionation and Dosage:

Conventional Fractionation Group: Applicable for larger target volumes (>5 cm diameter) or involvement of mediastinal lymph nodes. Total dose: 45-60 Gy; single fraction dose: 1.8-2.0 Gy; administered once daily (Qd).

Stereotactic Body Radiotherapy (SBRT) Group: Applicable for oligometastatic lesions (≤3 lesions, each ≤3 cm diameter). Total dose: 30-50 Gy delivered in 3-5 fractions; single fraction dose: 6-10 Gy.

Maintenance Therapy: Pucotenlimab (HX008) monotherapy until disease progression (defined by RECIST 1.1), investigator-assessed radiographic progression, unacceptable toxicity, withdrawal of consent, or fulfillment of criteria for discontinuation of intervention.

Being tested
Pucotenlimab, Becotatug vedotin, Radiotherapy
Keywords
Becotatug vedotin, Pucotenlimab, Sequential radiotherapy, Driver gene-negative NSCLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • PucotenlimabDrug

    Administered from Cycle 1 to Cycle 4 at a dose of 3 mg/kg (maximum 200 mg), once every 3 weeks on Day 1 (D1). Intravenous infusion (60 ± 15 minutes; first cycle infusion duration not less than 60 minutes).

    Maintenance Therapy: Pucotenlimab monotherapy until disease progression (defined by RECIST 1.1), investigator-assessed radiographic progression, unacceptable toxicity, withdrawal of consent, or fulfillment of criteria for discontinuation of intervention.

  • Becotatug vedotinDrug

    Administered from Cycle 1 to Cycle 4 at a dose of 2.0 mg/kg, once every 3 weeks on D1. Administration begins at least 30 minutes after the completion of Pucotenlimab infusion. Intravenous infusion (60 ± 10 minutes; first cycle infusion duration not less than 60 minutes).

  • RadiotherapyRadiation

    Investigators may opt to include sequential radiotherapy based on tumor size, number, location, extent of invasion, and individual patient factors.

Study groups in NCT07627321
Study groupRoleWhat they receive
ExperimentalExperimental1. Pucotenlimab (HX008): Administered from Cycle 1 to Cycle 4 at a dose of 3 mg/kg (maximum 200 mg), once every 3 weeks on Day 1 (D1). IV. 2. Becotatug vedotin (MRG003): Administered from Cycle 1 to Cycle 4 at a dose of 2.0 mg/kg, once every 3 weeks on D1. IV. 3. Radiotherapy: Investigators may opt to include sequential radiotherapy based on tumor size, number, location, extent of invasion, and individual patient factors. Maintenance Therapy: Pucotenlimab monotherapy until disease progression (defined by RECIST 1.1), investigator-assessed radiographic progression, unacceptable toxicity, withdrawal of consent, or fulfillment of criteria for discontinuation of intervention.
Receives: Drug: Pucotenlimab; Drug: Becotatug vedotin; Radiation: Radiotherapy

What is being measured

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

  1. Objective Response Rate

    ORR is defined as the proportion of subjects achieving confirmed CompleteResponse (CR) or Partial Response (PR) as assessed by the investigator according to RECISTV1.1 and iRECIST criteria. ORR analysis will be based on the Full Analysis Set (FAS)

    Measured: up to 2 years

Secondary outcomes (5)

  1. Disease Control Rate

    rerese control ete o dfined r ts roprte s suhiect seser o theStable Disease (SD) (lasting for at least 6 weeks from the first dose), along with the exact 95% CIIsing the Clopper-Pearson method.

    Measured: up to 2 years

  2. Progression-Free Survival

    : Progression-Free Survival (PFS) is defined as the time from enrollment to the firstoccurrence of disease progression or death from any cause. For subjects without observedprogression or death, PFS will be censored at the time of the last valid and adequate assessment.FS analysis will be based on the FAS. The median PFS and its 95% CI will be estimated using theKaplan-Meier method, and progression-free survival curves will be generated.

    Measured: up to 2 years

  3. Overall Survival

    Overall Survival (OS) is defined as the time from enrollment to death from any causeFor subjects not followed up to death, OS will be censored at the time of the last valid survival ollow-up. Based on the FAS, the median OS (if applicable) and its 95% CI will be estimated using the Kaplan-Meier method, and survival curves will be plotted.

    Measured: up to 2 years

  4. .Duration of Response

    :Duration of Response (DOR) is defined as the time from the first documentedevidence of response (PR or CR according to RECIST v1.1 and iRECIST criteria, whichever is later)to the first documented disease progression (PD) or death from any cause, whichever occurs first,in subjects with a confirmed response. For subjects without observed progression or death, DORvill be censored at the time of the last adequate tumor assessment. DOR analysis will beperformed on subjects who achieve CR or PR. The median DOR and its 95% CI will be estimatedIsing the Kaplan-Meier method, and duration of response curves will be generated.

    Measured: up to 2 years

  5. Safety Endpoints

    Incidence of adverse events (AEs), serious adverse events (SAEs), treatment-related adverse events (TRAEs), and immune-related adverse events (irAEs); severity grading; and laboratory abnormalities, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0.

    Measured: up to 2 years

Timeline

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

  1. First posted4 Jun 2026
  2. Study start15 Jul 2026 (estimated)
  3. Primary completion16 Jul 2028 (estimated)
  4. Study completion16 Jul 2029 (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
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07627321
Sponsor's protocol ID
PRAD2
Acronym
PRAD2
Status last verified
Jun 2026
First submitted
1 Jun 2026
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pucotenlimab, Becotatug vedotin and Radiotherapy in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Anhui Provincial Cancer Hospital 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 26 inclusion and 24 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 4 Jun 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 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?

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 ShangHu Yuan, MD (86+ 13853106916, yuanshuanghu@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: up to 2 years). 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 NCT07627321.

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 4 Jun 2026.

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PRAD2 Clinical Trial NCT07627321 | AzTrials