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Lung Cancer (NSCLC)Phase 1/2PrecisionNCT07486648

Osimertinib Plus Capivasertib in NSCLC With PIK3CA/AKT1/PTEN Alterations Following Prior 1L Osimertinib

A Phase 1/2 study testing Capivasertib in combination with Osimertinib in people with Lung Cancer (NSCLC) and Lung Cancer (Non-Small Cell), run by Shanxi Province Cancer Hospital at 2 sites 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 goal of this clinical trial is to learn if Osimertinib plus Capivasertib works to treat EGFRm advanced non-small cell lung cancer (NSCLC) in participants with PIK3CA/AKT1/PTEN alterations after progression on first-line Osimertinib (monotherapy or plus chemotherapy). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Capivasertib in combination with Osimertinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
2 sitesChina
Study dates
15 May 2026to 31 Dec 2028
Phase
Phase 1/2
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

  • Informed consent
  • Provision of signed and dated, written informed consent form (ICF) prior to any mandatory and non-mandatory study-specific procedures, sampling and analyses
  • Age
  • Male or female age ≥18 years at the time of signing the ICF.
  • Type of participant and disease characteristics
  • Histologically or cytologically confirmed non-squamous locally advanced or metastatic NSCLC which is not amenable to curative therapy.
Show all 84Show fewer
  • Documented EGFR sensitive mutations (exon19 deletion, L858R mutation) prior to the first-line EGFR-TKI therapy.
  • Documented radiologic progression on first-line treatment with Osimertinib monotherapy or Osimertinib plus chemotherapy:
  • Participants treated with Osimertinib in the adjuvant setting can be included if progression occurred < 6 months after last dose.
  • Participants must be immunotherapy (i.e., programmed cell death protein 1 [PD-1] inhibitor, programmed cell death protein 1 ligand 1 [PD-L1] inhibitor, Cytotoxic T-lymphocyte associated protein 4 inhibitor) naïve in the metastatic setting.
  • Prior immunotherapy in the neoadjuvant or adjuvant setting is acceptable providing treatment was completed more than 6 months before metastatic/recurrent disease was diagnosed.
  • Mandatory provision of the required number of FFPE tumour tissue samples for PIK3CA mutations and/or AKT1 mutations and/or PTEN loss-of-function (LOF) mutations testing, which fulfils the following requirements:
  • Obtained following progression on previous Osimertinib monotherapy or Osimertinib plus chemotherapy as first-line treatment.
  • Specimen to meet the requirements defined in the Central Laboratory Manual and Diagnostic Testing Manual.
  • Have PIK3CA and/or AKT1 and/or PTEN alterations as determined by NGS testing by a sponsor designated central laboratory on tumour specimen collected following progression on prior Osimertinib treatment.
  • At least one lesion, not previously irradiated, not biopsied during the screening period, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with CT or MRI, which is suitable for accurate repeated measurements. If only one measurable lesion exists, it is acceptable to be used if baseline tumour assessment scans are done at least 14 days after the screening tumour specimen collection is performed.
  • Adequate bone marrow reserve and organ function as follows:
  • Absolute neutrophils count (ANC) ≥1.5x109/L.
  • Platelets count ≥100x109/L.
  • Haemoglobin (Hb) ≥90g/L.
  • Total bilirubin ≤1.5 times upper limit of normal (ULN) or ≤3 times ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or liver metastases.
  • Alanine transaminase (ALT) and aspartate transaminase (AST) ≤2.5ULN (or ≤5 ULN in the presence of liver metastases).
  • Serum Creatinine ≤1.5 ULN or creatinine clearance (CCr) ≥50mL/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patients with hepatitis B virus (HBV) are only eligible for inclusion if they meet all the following criteria:
  • Demonstrated absence of hepatitis C virus (HCV) co-infection or history of HCV co-infection
  • Demonstrated absence of human immunodeficiency virus (HIV) infection
  • Participants with active HBV infection are eligible if they are:
  • Receiving anti-viral treatment for at least 6 weeks prior to study treatment, HBV DNA is suppressed to <100 IU/mL and transaminase levels are below ULN.
  • Participants with a resolved or chronic HBV infection are eligible if they are:
  • Negative for HBsAg and positive for hepatitis B core antibody [anti-HBc IgG or total anti-HBc Ab]. In addition, patients should be referred to a local hepatologist and treated as per local guidelines.
  • or
  • Positive for HBsAg, but for > 6 months have had transaminases levels below ULN and HBV DNA levels below <100 IU/mL or below the detectable limit of locally available test kit (i.e., are in an inactive carrier state). In addition, patients must be receiving anti-viral prophylaxis for 2-4 weeks prior to study treatment.
  • Patients with HIV are only eligible for inclusion if they meet all the following criteria:
  • Demonstrated absence of HBV/ HCV co-infection
  • Undetectable viral RNA load for 6 months
  • CD4+ count of >350 cells/µL
  • No history of AIDS-defining opportunistic infection within the past 12 months
  • Stable for at least 4 weeks on the same anti-HIV medications.
  • Ability to swallow and retain oral medications.
  • Willingness and ability to comply with study and follow-up procedures. Reproduction
  • Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
  • Post-menopausal defined as aged 50 years or more and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.
  • Women under 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution.
  • Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
  • Further information in Appendix C (Definition of Women of Childbearing Potential and Acceptable Contraceptive Methods).
  • Male participants must be willing to use barrier contraception. Exclusion criteria
  • Medical conditions
  • Patients harbouring concurrent actionable driver mutations with locally approved targeted therapies (e.g., MET amplification) will be excluded.
  • Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
  • Clinically significant abnormalities of glucose metabolism as defined by any of the following:
  • Fasting glucose ≥7.0 mmol/L (126 mg/dL) or 2 hours after glucose solution intake, blood glucose ≥11.1 mmol/L (200 mg/dL).
  • HbA1c ≥8.0% (63.9 mmol/mol) at screening. Note: for any patient with evidence of impaired glucose control or insulin resistance refer to the Capivasertib Toxicity Management Guidelines.
  • Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol, or active infection (e.g. patients receiving treatment for infection) including hepatitis C and human immunodeficiency virus (HIV), or active uncontrolled hepatitis B virus (HBV) infection, or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice) .
  • Screening for chronic conditions is not required.
  • Spinal cord compression, leptomeningeal metastasis, or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
  • Any of the following cardiac criteria:
  • Mean resting corrected QTc >470 msec, obtained from triplicate electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value.
  • History of QT prolongation associated with other medications that required discontinuation of that medication.
  • Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third degree heart block and second-degree heart block.
  • Medical history significant for arrhythmia (e.g., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (Common Terminology Criteria for Adverse Events [CTCAE] Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted to enter the study based on the Investigator judgement with cardiologist consultation recommended.
  • Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as electrolyte abnormalities including:
  • Hypokalaemia|* ≥ CTCAE Grade 2.
  • Heart failure, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsade de Pointes.
  • Correction of electrolyte abnormalities should be documented prior to first dose.
  • Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) Grade 2.
  • History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥2 years before the first dose of investigational product (IP) and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease.
  • Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment except for alopecia and grade 2 prior platinum-therapy related neuropathy. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the Investigator may be included (e.g., hearing loss).
  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of IP.
  • Any other disease, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
  • Prior/concomitant therapy
  • Prior or current treatment with a third-generation EGFR-TKI other than Osimertinib.
  • Prior or current treatment with any PI3K/AKT pathway inhibitors, including but not limited to: Capivasertib or other AKT inhibitors, PI3K inhibitors, or agents targeting key nodes in this pathway (e.g., PTEN-modulating therapies).
  • Concurrent use of herbal or natural products intended as treatment or prophylaxis for any type of cancer.
  • Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study intervention or has not recovered from side effects of such therapy.
  • Major surgery or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study. Procedures such as placement of vascular access, biopsy via mediastinoscopy or biopsy via video assisted thoracoscopic surgery (VATS) are permitted.
  • Systemic therapy: Prior exposure to any anti-cancer agents other than those specified in the protocol (e.g. hormonal therapy such as luteinizing hormone releasing hormone [LHRH] agonists) without appropriate washout period before enrolment, for example, enrolment within 3 half-lives of a small molecule anti-cancer agent, or within 4 weeks for any antibody-based anticancer agents.
  • Participants currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers (at least 3-week prior), moderate inducers (at least 2-week prior) or strong inhibitors of CYP3A4 (at least 2-week prior). All participants must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer or inhibitor effects on CYP3A4. Any concomitant medication that may interfere with Osimertinib safety and efficacy based on the prescribing information of Osimertinib and local clinical guidelines.
  • Prior/concurrent clinical study experience
  • Participation in another clinical study with a study intervention or investigational medicinal device administered in the 4 weeks prior to first dose of study intervention or concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
  • Other exclusions
  • History of hypersensitivity to active or inactive excipients of Capivasertib or Osimertinib or drugs with a similar chemical structure or class.
  • Women who are currently pregnant (confirmed with positive pregnancy test) or breast-feeding or planning to become pregnant.
  • Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).

Who cannot join

None listed.

Trial locations and contacts

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

Jie Wang contact

+86-0351-4881611

15234165176@163.com

China2 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

    Jiachen Xu, +86-010-87788525, cancergcp@163.com

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi

    Jinfang Zhai, +86-0351-4881611, 15234165176@163.com

Other trials in China

About this study

Official title: The Safety and Efficacy of Osimertinib Plus Capivasertib in EGFRm Advanced Non-small Cell Lung Cancer (NSCLC) Participants With PIK3CA/AKT1/PTEN Alterations Who Had Progressed on First-line Osimertinib Monotherapy or Plus Chemotherapy: a First-in-human, Phase Ib/Ⅱa Study (PRECISION)

The goal of this clinical trial is to learn if Osimertinib plus Capivasertib works to treat EGFRm advanced non-small cell lung cancer (NSCLC) in participants with PIK3CA/AKT1/PTEN alterations after progression on first-line Osimertinib (monotherapy or plus chemotherapy).

The main questions it aims to answer are:

Read more

Part A:

  • Number of Dose-limiting toxicities (DLTs)
  • Adverse events (AEs)/serious adverse events (SAEs) (graded by CTCAE Version 5.0)
  • Recommended combined dose (RCD)

Part B:Confirmed ORR assessed by the Investigator per RECIST 1.1 criteria.

Participants will:

Part A:Take Capivasertib twice daily from day 1 to 4 of a 7-day cycle, Osimertinib will be given orally QD(once daily) at 80 mg throughout the study treatment period.

Part B: Take Osimertinib (80mg QD, continuously) and Capivasertib(RCD,orally BID from day1-day 4 in 7-day cycle , 4 days on /3 days off) till disease progression (PD) or unacceptable toxicity.

Read the detailed description

This is a two-stage study, consisting of Phase Ib dose-escalation, Phase IIa dose expansion. Safety will be intensively monitored in Part A. If RCD (Recommended combined dose) was not reached in Part A, Part B (dose expansion phase) would not be initiated. If RCD was reached in Part A, eligible patients in Part B will be enrolled and receive Osimertinib (80mg QD, continuously) plus Capivasertib (RCD, orally BID from day1-day 4 in 7-day cycle , 4 days on /3 days off) till disease progression (PD) or unacceptable toxicity, with the aim to further evaluate the safety, tolerability and efficacy in terms of ORR, DCR, DOR, PFS and OS.

All participants (18 and above) will undergo screening (Day -28 to -1), treatment period (starting from Day 1) and post-intervention follow-up period (end of treatment visit, 30-day safety follow-up and survival follow-up).

Dose escalation(Part A) will follow the classic "3+3" schema. The DLT observation period is 28 days post first dose of study treatment. Dose escalation will occur only after DLT observation period is completed for a minimum of 3 participants, relevant data has been reviewed within the Safety Review Committee (SRC), and the SRC approves dose escalation.

Being tested
Capivasertib in combination with Osimertinib
Keywords
NSCLC, Osimertinib plus Capivasertib
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Capivasertib in combination with OsimertinibDrug

    Capivasertib 320/400 mg(twice daily from day 1 to 4 of a 7-day cycle ),Osimertinib 80 mg(once daily continuously),28 days per cycle

Study groups in NCT07486648
Study groupRoleWhat they receive
Capivasertib 320/400 mg in combination with Osimertinib 80mgExperimentalCapivasertib 320/400 mg (twice daily from day 1 to 4 of a 7-day cycle ),Osimertinib 80 mg( once daily continuously),28 days per cycle
Receives: Drug: Capivasertib in combination with Osimertinib

What is being measured

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

  1. Part A Number of Dose-limiting toxicities (DLTs)

    A DLT is defined as any toxicity related to study drug and not attributable to the disease or disease-related processes under investigation, which occurs from the first dose of study treatment (Day 1, Cycle 0) up to the last day of Cycle 1 (28 days after start of dosing)

    Measured: 28 days post first dose of study treatment

  2. Part A Adverse events (AEs)/serious adverse events (SAEs) (graded by CTCAE Version 5.0)

    Measured: From the time of signature of informed consent form up to 44 months

  3. Part A Recommended combined dose (RCD)

    The RCD is defined as the optimal dose combination of study drugs, established based on integrated assessment of safety and relevant available data from dose escalation phase

    Measured: From first dose of study treatment up to 12 months

  4. Part B Confirmed ORR assessed by the Investigator per RECIST 1.1 criteria

    ORR is defined as the percentage of participants who have at least one confirmed response of CR or PR prior to any evidence of progression (as determined by investigator at local site per RECIST 1.1)

    Measured: 5 months post first dose of study treatment

Secondary outcomes (8)

  1. Part A Confirmed ORR assessed by the Investigator per RECIST 1.1 criteria

    Confirmed ORR as defined in Primary Outcome Measure 4

    Measured: 5 months post first dose of study treatment

  2. Part B Progression-free survival(PFS)

    PFS is defined as the time from initiation of study treatment to the date of objective disease progression or death (by any cause in the absence of progression), which occurs first, regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy prior to progression

    Measured: From first dose of study treatment up to 27 months

  3. Part B Duration of response(DoR )

    DOR will be defined as the time from the date of first documented response (which is subsequently confirmed), until date of documented progression or death in the absence of disease progression

    Measured: From 1 months post first dose of study treatment up to 27 months

  4. Part B Disease control rate(DCR)

    Disease control rate is defined as the proportion of patients with a best overall response of confirmed CR, confirmed PR, or SD

    Measured: From 2 months post first dose of study treatment up to 27 months

  5. Part B Overall survival(OS)

    Overall survival is defined as the time from the date of initiation of study treatment until death due to any cause

    Measured: From first dose of study treatment up to 27 months

  6. Part B AE/SAE

    Number of participants with adverse events (AEs) according to CTCAE 5.0

    Measured: From the time of signature of informed consent form up to 28 months

  7. Part B Adverse drug reactions(ADR)

    Measured: From the time of signature of informed consent form up to 28 months

  8. Part B Adverse events of special interest(AESI)

    AESIs are events of scientific and medical interest specific to the further understanding of the safety profile of Capivasertib plus Osimertinib when given in combination and require close monitoring and rapid communication by the investigators to AstraZeneca. An AESI can be serious or nonserious

    Measured: From the time of signature of informed consent form up to 28 months

Timeline

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

  1. First posted20 Mar 2026
  2. Study start15 May 2026 (estimated)
  3. Primary completion15 Oct 2028 (estimated)
  4. Study completion31 Dec 2028 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
The study includes 2 parts:Part A:Dose escalation; Part B:Dose expansion
Masking
None (open label)
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07486648
Sponsor's protocol ID
ESR-25-22924
Acronym
Precision
Status last verified
Mar 2026
First submitted
25 Feb 2026
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Masters GA, Temin S, Azzoli CG, Giaccone G, Baker S Jr, Brahmer JR, Ellis PM, Gajra A, Rackear N, Schiller JH, Smith TJ, Strawn JR, Trent D, Johnson DH; American Society of Clinical Oncology Clinical Practice. Systemic Therapy for Stage IV Non-Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2015 Oct 20;33(30):3488-515. doi: 10.1200/JCO.2015.62.1342. Epub 2015 Aug 31.

    PubMed 26324367

  • Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

    PubMed 19097774

  • Chinese Society of Clinical Oncology. Non-small Cell Lung Cancer. 2025.

  • Lu S, Wu L, Jian H, Cheng Y, Wang Q, Fang J, et al. VP9-2021: ORIENT-31: Phase III study of sintilimab with or without IBI305 plus chemotherapy in patients with EGFR mutated non squamous NSCLC who progressed after EGFR-TKI therapy. ESMO Virtual Plenary Abstract. 2022 Jan; 33 (1): 112-113

  • Yip PY. Phosphatidylinositol 3-kinase-AKT-mammalian target of rapamycin (PI3K-Akt-mTOR) signaling pathway in non-small cell lung cancer. Transl Lung Cancer Res. 2015 Apr;4(2):165-76. doi: 10.3978/j.issn.2218-6751.2015.01.04.

    PubMed 25870799

  • Yang JC, Robichaux J, Planchard D, Kobayashi K, Lee CK, Sugawara S, et al. FLAURA2: Resistance, and Impact of Baseline TP53 Alterations in Patients Treated With 1L Osimertinib ± Platinum-Pemetrexed. 2024 WCLC. Abstract MA12.03

  • Wang W, Li J, Ma S, Li H, Gao Z, Qu M. EGFR TKIs Combinding the inhibition of RAS-ERK signaling in NSCLC Treatment. J Clin Res Oncol 2021; 4(1): 1-9

  • Wang J, Wang B, Chu H, Yao Y. Intrinsic resistance to EGFR tyrosine kinase inhibitors in advanced non-small-cell lung cancer with activating EGFR mutations. Onco Targets Ther. 2016 Jun 22;9:3711-26. doi: 10.2147/OTT.S106399. eCollection 2016.

    PubMed 27382309

  • Vokes NI, Le X, Yap TA. PIKing up and AKTing on Resistance Mutations in Osimertinib-Treated EGFR-Mutated NSCLC. Clin Cancer Res. 2024 Sep 13;30(18):3968-3970. doi: 10.1158/1078-0432.CCR-24-1188.

    PubMed 39018064

  • Soria JC, Ohe Y, Vansteenkiste J, Reungwetwattana T, Chewaskulyong B, Lee KH, Dechaphunkul A, Imamura F, Nogami N, Kurata T, Okamoto I, Zhou C, Cho BC, Cheng Y, Cho EK, Voon PJ, Planchard D, Su WC, Gray JE, Lee SM, Hodge R, Marotti M, Rukazenkov Y, Ramalingam SS; FLAURA Investigators. Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2018 Jan 11;378(2):113-125. doi: 10.1056/NEJMoa1713137. Epub 2017 Nov 18.

    PubMed 29151359

  • Sirico M, D'Angelo A, Gianni C, Casadei C, Merloni F, De Giorgi U. Current State and Future Challenges for PI3K Inhibitors in Cancer Therapy. Cancers (Basel). 2023 Jan 23;15(3):703. doi: 10.3390/cancers15030703.

    PubMed 36765661

  • Reck M, Popat S, Reinmuth N, De Ruysscher D, Kerr KM, Peters S; ESMO Guidelines Working Group. Metastatic non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014 Sep;25 Suppl 3:iii27-39. doi: 10.1093/annonc/mdu199. Epub 2014 Aug 11. No abstract available.

    PubMed 25115305

  • Goldstein P. The synaptonemal complexes of Caenorhabditis elegans: pachytene karyotype analysis of hermaphrodites from the recessive him-5 and him-7 mutants. J Cell Sci. 1986 Jun;82:119-27. doi: 10.1242/jcs.82.1.119.

    PubMed 3793776

  • Passaro A, Wang J, Wang Y, Lee SH, Melosky B, Shih JY, Wang J, Azuma K, Juan-Vidal O, Cobo M, Felip E, Girard N, Cortot AB, Califano R, Cappuzzo F, Owen S, Popat S, Tan JL, Salinas J, Tomasini P, Gentzler RD, William WN Jr, Reckamp KL, Takahashi T, Ganguly S, Kowalski DM, Bearz A, MacKean M, Barala P, Bourla AB, Girvin A, Greger J, Millington D, Withelder M, Xie J, Sun T, Shah S, Diorio B, Knoblauch RE, Bauml JM, Campelo RG, Cho BC; MARIPOSA-2 Investigators. Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study. Ann Oncol. 2024 Jan;35(1):77-90. doi: 10.1016/j.annonc.2023.10.117. Epub 2023 Oct 23.

    PubMed 37879444

  • NMPA approval of Capivasertib

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Capivasertib in combination with Osimertinib in people with Lung Cancer (NSCLC) and Lung Cancer (Non-Small Cell), run by Shanxi Province Cancer Hospital at 2 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 84 inclusion and 0 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 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Jie Wang (+86-0351-4881611, 15234165176@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A Number of Dose-limiting toxicities (DLTs) (time frame: 28 days post first dose of study treatment). 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 NCT07486648, which also lists 36 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 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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