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Extensive Small Cell Lung CancerPhase 2QL1706NCT07083375

A Phase II Study of QL1706 With Anti-angiogenesis Therapy and Chemotherapy in Extensive-stage Small Cell Lung Cancer.

A Phase 2 study testing QL1706 , bevacizumab, etoposide , cisplatin or carboplatin in people with Extensive Small Cell Lung Cancer, run by Zhijie Wang 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 single-arm, open-label, Phase II study assesses first-line QL1706 + bevacizumab (anti-VEGF) + platinum/etoposide chemotherapy to treat naïve ES-SCLC patients.The main questions it aims to answer are: Evaluate efficacy and safety of this quadruplet regimen in ES-SCLC Explore correlations between tumor biomarkers… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Extensive Small Cell Lung Cancer
What is being tested?
QL1706 , bevacizumab, etoposide , cisplatin or carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteChina
Study dates
1 Aug 2025to 1 Jun 2027
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all of the following criteria to be eligible for the study:
  • Signed written informed consent and willingness to comply with study procedures.
  • Age ≥18 years.
  • Estimated life expectancy ≥3 months.
  • ECOG performance status of 0 or 1.
  • Histologically or cytologically confirmed, treatment-naïve extensive-stage small cell lung cancer (ES-SCLC).
Show all 17Show fewer
  • Willing to provide archived or fresh tumor tissue samples. If unavailable, enrollment may proceed per investigator assessment.
  • At least one measurable lesion per RECIST v1.1.
  • Fully understands and voluntarily participates in the study.
  • Adequate organ function as defined below:
  • Absolute neutrophil count ≥1.5 × 10⁹/L
  • Platelets ≥100 × 10⁹/L
  • Hemoglobin ≥90 g/L (without transfusion in prior 14 days)
  • Serum creatinine ≤1× ULN or creatinine clearance >50 mL/min (Cockcroft-Gault)
  • AST and ALT ≤2.5× ULN (≤5× ULN with liver metastases)
  • Total bilirubin ≤1.5× ULN (except Gilbert's syndrome <51.3 µmol/L)
  • TSH, FT3, FT4 within ±10% of normal limits

Who cannot join

  • Prior chemotherapy, immunotherapy, targeted therapy, or radiotherapy.
  • Histologic or cytologic evidence of non-small cell or mixed small cell/non-small cell carcinoma.
  • Symptomatic brain metastases or leptomeningeal disease.
  • Active or suspected autoimmune disease, except for stable vitiligo, type 1 diabetes, hypothyroidism requiring only hormone replacement, or conditions not expected to recur.
  • Evidence or history of active pulmonary tuberculosis (TB), including treated TB within the past year.
  • Concomitant condition requiring systemic corticosteroids or other immunosuppressive therapy.
Show all 21Show fewer
  • Pregnant or breastfeeding females.
  • Symptomatic interstitial lung disease or suspected drug-related pneumonitis.
  • Positive for HIV antibodies, active HBV (HBsAg+ with HBV DNA >10³ copies/mL), or active HCV infection (HCV-Ab+ with detectable RNA).
  • History of significant neurological or psychiatric disorders (e.g., dementia, depression, epilepsy, bipolar disorder).
  • Participation in another investigational drug study within 4 weeks prior to randomization.
  • Use of anti-tumor traditional Chinese medicine within 2 weeks prior to first study dose.
  • History of other malignancies within 2 years, except for cured non-melanoma skin cancers or certain in situ carcinomas.
  • Clinically significant cardiovascular or cerebrovascular disease (e.g., NYHA class ≥2 heart failure, recent myocardial infarction or stroke within 6 months).
  • History of thromboembolic events (e.g., DVT, PE, arterial thrombosis) within 6 months, except catheter-related thrombosis.
  • Live vaccination within 28 days before randomization or planned during the study.
  • Major surgery or significant trauma within 4 weeks prior to treatment initiation.
  • Conditions affecting drug absorption (e.g., severe vomiting, GI obstruction, active GI bleeding or perforation).
  • Active, uncontrolled bacterial, viral, or fungal infections despite appropriate treatment.
  • Known hypersensitivity to any study drug or excipients.
  • Any other condition deemed unsuitable by the investigator due to safety or compliance concerns.

Trial locations and contacts

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

Zhijie Wang, MD contact

+86 13466323860

jie_969@163.com

China1 site

  • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing 100021

    Beijing, Beijing Municipality, 100021

    Zhijie Wang, MD, +8613466323860, jie_969@163.com

Other trials in China

About this study

Official title: A Phase II Clinical Trial of Iparomlimab and Tuvonralimab in Combination With Bevacizumab and Platinum-based Chemotherapy in Previously Untreated Patients With Extensive-stage Small Cell Lung Cancer.

This single-arm, open-label, Phase II study assesses first-line QL1706 + bevacizumab (anti-VEGF) + platinum/etoposide chemotherapy to treat naïve ES-SCLC patients.The main questions it aims to answer are:

Evaluate efficacy and safety of this quadruplet regimen in ES-SCLC Explore correlations between tumor biomarkers and treatment efficacy

Participants will:

Histologically or cytologically confirmed, treatment-naïve extensive-stage small cell lung cancer (ES-SCLC).

Willing to provide archived or fresh tumor tissue samples. If unavailable, enrollment may proceed per investigator assessment.

At least one measurable lesion per RECIST v1.1

Read the detailed description

Small cell lung cancer (SCLC) is a highly aggressive malignancy, accounting for 13-15% of all lung cancers. Approximately two-thirds of patients present with distant metastases at diagnosis, defined as extensive-stage SCLC (ES-SCLC). Prognosis remains poor, with median overall survival (mOS) of 12-15 months despite standard first-line chemotherapy using etoposide plus cisplatin/carboplatin (EP/EC), which offers limited benefit (mOS ~10 months; median progression-free survival [mPFS] ~5 months).

Immune checkpoint inhibitors (ICIs) have improved outcomes modestly. IMpower133, KEYNOTE-604, RATIONALE-312, and EXTENTORCH trials confirmed the benefit of adding PD-1/PD-L1 inhibitors to chemotherapy, but the survival plateau remains. Dual immune checkpoint blockade strategies, including PD-1/PD-L1 with CTLA-4 inhibitors, have not significantly improved outcomes and pose higher toxicity, as seen in CASPIAN and CheckMate451 studies.

Antiangiogenic therapy offers another promising direction. Studies such as SALUTE, ACTION-2, and BEAT-SC have explored bevacizumab or anlotinib combined with chemo-immunotherapy, showing potential survival gains. Notably, the ETER701 study using a four-drug combination achieved mOS of 19.3 months, although with increased adverse events.

QL1706 (Aito combination antibody) is a novel bifunctional antibody targeting PD-1 and CTLA-4 in a 2:1 fixed ratio, designed to optimize synergy while reducing CTLA-4 toxicity. Approved in 2024, it has demonstrated efficacy and tolerability in multiple solid tumors. In NSCLC, QL1706 combined with chemotherapy and antiangiogenic therapy showed mPFS up to 8.5 months and mOS of 26.5 months.

To date, no clinical data exist for QL1706 combined with antiangiogenic therapy and chemotherapy in ES-SCLC. A phase II, open-label, single-arm clinical trial is proposed to evaluate its efficacy and safety as first-line treatment. This study aims to explore a new therapeutic strategy to overcome the current survival limitations in ES-SCLC.

Being tested
QL1706 , bevacizumab, etoposide , cisplatin or carboplatin
Keywords
QL1706, Extensive Small Cell Lung Cancer, combination therapy, first line therapy

What participants receive

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

  • QL1706 , bevacizumab, etoposide , cisplatin or carboplatinDrug

    Participants will receive QL1706 (5 mg/kg, IV, day 1), bevacizumab (7.5 mg/kg, IV, day 1), etoposide (100 mg/m², IV, days 1-3), plus either cisplatin (75 mg/m² split over days 1-2, IV) or carboplatin (AUC=5, IV, day 1) every 21 days for 4-6 cycles. Dose adjustments may be made based on clinical judgment. Patients who do not experience disease progression or intolerable toxicity will proceed to maintenance therapy with QL1706 (5 mg/kg, IV, day 1) and bevacizumab (7.5 mg/kg, IV, day 1) every 21 days, continued until disease progression, unacceptable toxicity, consent withdrawal, investigator decision, loss to follow-up, death, or other protocol-defined criteria. All participants will receive dual-agent maintenance therapy.

Study groups in NCT07083375
Study groupRoleWhat they receive
combined treatment groupExperimentalThis study investigates a novel four-drug first-line treatment for extensive-stage small cell lung cancer (ES-SCLC), combining QL1706-a bifunctional antibody targeting both PD-1 and CTLA-4-with bevacizumab (anti-VEGF) and platinum-based chemotherapy (etoposide + cisplatin or carboplatin). QL1706 is uniquely engineered to provide dual checkpoint inhibition with reduced CTLA-4 exposure, potentially enhancing efficacy while limiting immune-related toxicity. Bevacizumab adds antiangiogenic activity, aiming to improve immune infiltration and drug delivery. This synergistic approach integrates immunotherapy, antiangiogenesis, and cytotoxic agents to overcome resistance and extend survival. All patients receive dual-agent maintenance (QL1706 + bevacizumab) post-induction. No prior studies have evaluated this specific combination in ES-SCLC.
Receives: Drug: QL1706 , bevacizumab, etoposide , cisplatin or carboplatin

What is being measured

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

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from the first dose of study treatment to the first documentation of disease progression according to RECIST v1.1 (as assessed by investigators) or death from any cause, whichever occurs first. Subjects who are alive without progression at the time of analysis will be censored at the date of the last tumor assessment.

    Measured: From enrollment to the end of monitoring at 2 years.

Secondary outcomes (5)

  1. Overall Survival (OS)

    OS is defined as the time from the first dose of study treatment to death from any cause. Subjects who are alive at the time of analysis will be censored at the date of last follow-up.

    Measured: From enrollment to the end of monitoring at 2 years.

  2. Objective Response Rate (ORR)

    ORR is defined as the proportion of subjects who achieve a complete response (CR) or partial response (PR) as per RECIST v1.1.

    Measured: From enrollment to the end of monitoring at 2 years.

  3. Duration of Response (DoR)

    DoR is defined as the time from the first documentation of CR or PR to the first documentation of disease progression or death.

    Measured: From enrollment to the end of monitoring at 2 years.

  4. Disease Control Rate (DCR)

    DCR is defined as the proportion of subjects who achieve CR, PR, or stable disease (SD) as their best overall response.

    Measured: From enrollment to the end of monitoring at 2 years.

  5. The incidence of adverse events

    Incidence, nature, and severity of adverse events (AEs), graded according to NCI-CTCAE v5.0, including immune-related AEs and serious AEs.

    Measured: From enrollment to the end of monitoring at 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 posted24 Jul 2025
  2. Study start1 Aug 2025 (estimated)
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Jun 2027 (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
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07083375
Sponsor's protocol ID
NCC5301
Acronym
QL1706
Status last verified
Jul 2025
First submitted
7 Jul 2025
Last updated
24 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang W, Deng P, Kong T, Zhang B, Qian F, Dong Y, Chen Y, Chen L, Liu D, Zhang Y, Yang H, Han B. Safety and efficacy of anlotinib in combination with standard chemotherapy as first-line treatment for extensive-stage small cell lung cancer: A multi-center, prospective study (ACTION-2). Lung Cancer. 2022 Nov;173:43-48. doi: 10.1016/j.lungcan.2022.09.003. Epub 2022 Sep 8.

    PubMed 36116169

  • Reck M, Luft A, Szczesna A, Havel L, Kim SW, Akerley W, Pietanza MC, Wu YL, Zielinski C, Thomas M, Felip E, Gold K, Horn L, Aerts J, Nakagawa K, Lorigan P, Pieters A, Kong Sanchez T, Fairchild J, Spigel D. Phase III Randomized Trial of Ipilimumab Plus Etoposide and Platinum Versus Placebo Plus Etoposide and Platinum in Extensive-Stage Small-Cell Lung Cancer. J Clin Oncol. 2016 Nov 1;34(31):3740-3748. doi: 10.1200/JCO.2016.67.6601.

    PubMed 27458307

  • Zhao Y, Ma Y, Zang A, Cheng Y, Zhang Y, Wang X, Chen Z, Qu S, He J, Chen C, Jin C, Zhu D, Li Q, Liu X, Su W, Ba Y, Hao Y, Chen J, Zhang G, Qu S, Li Y, Feng W, Yang M, Liu B, Ouyang W, Liang J, Yu Z, Kang X, Xue S, Yang G, Yan W, Yang Y, Liu Z, Peng Y, Fanslow B, Huang X, Zhang L, Zhao H. First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors. J Hematol Oncol. 2023 May 8;16(1):50. doi: 10.1186/s13045-023-01445-1.

    PubMed 37158938

  • Hong MMY, Maleki Vareki S. Addressing the Elephant in the Immunotherapy Room: Effector T-Cell Priming versus Depletion of Regulatory T-Cells by Anti-CTLA-4 Therapy. Cancers (Basel). 2022 Mar 20;14(6):1580. doi: 10.3390/cancers14061580.

    PubMed 35326731

  • Cheng Y, Chen J, Zhang W, Xie C, Hu Q, Zhou N, Huang C, Wei S, Sun H, Li X, Yu Y, Lai J, Yang H, Fang H, Chen H, Zhang P, Gu K, Wang Q, Shi J, Yi T, Xu X, Ye X, Wang D, Xie C, Liu C, Zheng Y, Lin D, Zhuang W, Lu P, Yu G, Li J, Gu Y, Li B, Wu R, Jiang O, Wang Z, Wu G, Lin H, Zhong D, Xu Y, Shu Y, Wu D, Chen X, Wang J, Wang M, Yang R. Benmelstobart, anlotinib and chemotherapy in extensive-stage small-cell lung cancer: a randomized phase 3 trial. Nat Med. 2024 Oct;30(10):2967-2976. doi: 10.1038/s41591-024-03132-1. Epub 2024 Jul 11.

    PubMed 38992123

  • Lamberti G, Rihawi K, Mazzoni F, Riccardi F, Follador A, Tiseo M, Frassoldati A, Colantonio I, Bonetti A, Genova C, Giardina D, Bertolini F, Cinieri S, Pasello G, Brighenti M, Andrini E, Tognetto M, Boni L, Ardizzoni A; GOIRC group. Carboplatin, etoposide, atezolizumab, and bevacizumab in the first-line treatment of patients with extensive stage small-cell lung cancer: the GOIRC-01-2019 CeLEBrATE study. J Immunother Cancer. 2025 May 7;13(5):e010694. doi: 10.1136/jitc-2024-010694.

    PubMed 40341031

  • Spigel DR, Townley PM, Waterhouse DM, Fang L, Adiguzel I, Huang JE, Karlin DA, Faoro L, Scappaticci FA, Socinski MA. Randomized phase II study of bevacizumab in combination with chemotherapy in previously untreated extensive-stage small-cell lung cancer: results from the SALUTE trial. J Clin Oncol. 2011 Jun 1;29(16):2215-22. doi: 10.1200/JCO.2010.29.3423. Epub 2011 Apr 18.

    PubMed 21502556

  • Xie M, Vuko M, Rodriguez-Canales J, Zimmermann J, Schick M, O'Brien C, Paz-Ares L, Goldman JW, Garassino MC, Gay CM, Heymach JV, Jiang H, Barrett JC, Stewart RA, Lai Z, Byers LA, Rudin CM, Shrestha Y. Molecular classification and biomarkers of outcome with immunotherapy in extensive-stage small-cell lung cancer: analyses of the CASPIAN phase 3 study. Mol Cancer. 2024 May 30;23(1):115. doi: 10.1186/s12943-024-02014-x.

    PubMed 38811992

  • Thomas BL, Tucker AS, Ferguson C, Qiu M, Rubenstein JL, Sharpe PT. Molecular control of odontogenic patterning: positional dependent initiation and morphogenesis. Eur J Oral Sci. 1998 Jan;106 Suppl 1:44-7. doi: 10.1111/j.1600-0722.1998.tb02152.x.

    PubMed 9541202

  • Cheng Y, Fan Y, Zhao Y, Huang D, Li X, Zhang P, Kang M, Yang N, Zhong D, Wang Z, Yu Y, Zhang Y, Zhao J, Qin T, Chen C, Leaw S, Zheng W, Song Y; RATIONALE-312 Study Group. Tislelizumab Plus Platinum and Etoposide Versus Placebo Plus Platinum and Etoposide as First-Line Treatment for Extensive-Stage SCLC (RATIONALE-312): A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase 3 Clinical Trial. J Thorac Oncol. 2024 Jul;19(7):1073-1085. doi: 10.1016/j.jtho.2024.03.008. Epub 2024 Mar 7.

    PubMed 38460751

  • Rudin CM, Awad MM, Navarro A, Gottfried M, Peters S, Csoszi T, Cheema PK, Rodriguez-Abreu D, Wollner M, Yang JC, Mazieres J, Orlandi FJ, Luft A, Gumus M, Kato T, Kalemkerian GP, Luo Y, Ebiana V, Pietanza MC, Kim HR; KEYNOTE-604 Investigators. Pembrolizumab or Placebo Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer: Randomized, Double-Blind, Phase III KEYNOTE-604 Study. J Clin Oncol. 2020 Jul 20;38(21):2369-2379. doi: 10.1200/JCO.20.00793. Epub 2020 May 29.

    PubMed 32468956

  • Horn L, Mansfield AS, Szczesna A, Havel L, Krzakowski M, Hochmair MJ, Huemer F, Losonczy G, Johnson ML, Nishio M, Reck M, Mok T, Lam S, Shames DS, Liu J, Ding B, Lopez-Chavez A, Kabbinavar F, Lin W, Sandler A, Liu SV; IMpower133 Study Group. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018 Dec 6;379(23):2220-2229. doi: 10.1056/NEJMoa1809064. Epub 2018 Sep 25.

    PubMed 30280641

  • Sokol R, Pluta P. ENDOPARASITES IN WESTERN CAPERCAILLIES (TETRAO UROGALLUS) AND BLACK GROUSE (TETRAO TETRIX) KEPT IN VARIOUS TYPES OF AVIARIES. J Wildl Dis. 2022 Jan 1;58(1):114-121. doi: 10.7589/JWD-D-21-00017.

    PubMed 34714912

  • Han S, Gelernter J, Kranzler HR, Yang BZ. Ordered subset linkage analysis based on admixture proportion identifies new linkage evidence for alcohol dependence in African-Americans. Hum Genet. 2013 Apr;132(4):397-403. doi: 10.1007/s00439-012-1255-2. Epub 2012 Dec 13.

    PubMed 23239122

  • Gazdar AF, Bunn PA, Minna JD. Small-cell lung cancer: what we know, what we need to know and the path forward. Nat Rev Cancer. 2017 Nov 10;17(12):765. doi: 10.1038/nrc.2017.106. Online ahead of print.

    PubMed 29123245

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QL1706 , bevacizumab, etoposide , cisplatin or carboplatin in people with Extensive Small Cell Lung Cancer, run by Zhijie Wang 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 17 inclusion and 21 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 24 Jul 2025. 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 Zhijie Wang, MD (+86 13466323860, jie_969@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: From enrollment to the end of monitoring at 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 NCT07083375, which also lists 16 linked publications.

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 24 Jul 2025.

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