Promising combo may delay drug resistance in lung cancer patients

NCT ID NCT04035486

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests whether adding chemotherapy to the targeted drug osimertinib (Tagrisso) helps people with advanced EGFR-mutated non-small cell lung cancer live longer without their cancer worsening. About 587 adults with newly diagnosed or recurrent advanced lung cancer will be randomly assigned to receive osimertinib alone or with chemo. The goal is to see if the combination delays resistance to treatment.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

587 people

The number who actually took part.

Started

Jul 2019

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 110 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female, at least 18 years of age; patients from Japan at least 20 years of age. 2. Pathologically confirmed non-squamous Non-Small Cell Lung Cancer (NSCLC). NSCLC of mixed histology is allowed. 3. Newly diagnosed locally advanced (clinical stage IIIB, IIIC) or metastatic Non-Small Cell Lung Cancer (NSCLC) (clinical stage IVA or IVB) or recurrent Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy. 4. The tumor harbors 1 of the 2 common epidermal growth factor receptor (EGFR) mutations known to be associated with Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) sensitivity (Ex19del or L858R), either alone or in combination with other epidermal growth factor receptor (EGFR) mutations, which may include T790M. 5. Patients must have untreated advanced Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy. 6. WHO PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks. 7. Life expectancy \>12 weeks at Day 1. 8. Willing to use contraception as appropriate during the study and for a period of time after discontinuing study treatment. Exclusion Criteria: 1. Spinal cord compression; and unstable brain metastases, with stable brain metastases who have completed definitive therapy, are not on steroids, and have a stable neurological status for at least 2 weeks after completion of the definitive therapy and steroids can be enrolled. Patients with asymptomatic brain metastases can be eligible for inclusion if in the opinion of the Investigator immediate definitive treatment is not indicated 2. Past medical history of Interstitial Lung Disease (ILD), drug-induced Interstitial Lung Disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active Interstitial Lung Disease. 3. 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 including Hep. B, Hep. C and HIV. Screening for chronic conditions is not required. Active infection will include any patients receiving treatment for infection. 4. QT prolongation or any clinically important abnormalities in rhythm. 5. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: * Absolute neutrophil count below the lower limit of normal (\<LLN) * Platelet count below the LLN * Hemoglobin \<90 g/L. The use of granulocyte colony stimulating factor support, platelet transfusion and blood transfusions to meet these criteria is not permitted. * ALT \>2.5 x the upper limit of normal (ULN) if no demonstrable liver metastases or \>5 x ULN in the presence of liver metastases * AST \>2.5 x ULN if no demonstrable liver metastases or \>5 x ULN in the presence of liver metastases * Total bilirubin \>1.5 x ULN if no liver metastases or \>3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases * Creatinine clearance \<60 mL/min calculated by Cockcroft and Gault equation or 24 hour urine collection (refer to Appendix I for appropriate calculation) 6. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib. 7. Prior treatment with any systemic anti-cancer therapy for advanced Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiation including chemotherapy, biologic therapy, immunotherapy, or any investigational drug. Prior adjuvant and neo-adjuvant therapies (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiation/chemoradiation with or without regimens including immunotherapy, biologic therapies, investigational agents are permitted as long as treatment was completed at least 12 months prior to the development of recurrent disease. 8. Prior treatment with an Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI). 9. Major surgery within 4 weeks of the first dose of investigational product (IP). Procedures such as placement of vascular access, biopsy via mediastinoscopy or biopsy via video assisted thoracoscopic surgery are permitted. 10. Radiotherapy treatment to more than 30% of the bone marrow or( with a wide field of radiation within 4 weeks of the first dose of investigational product (IP). 11. History of hypersensitivity to active or inactive excipients of investigational product (IP) or drugs with a similar chemical structure or class to investigational product (IP).

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Conditions

The condition(s) this trial relates to.

carcinoma Neoplasm Metastasis non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

Research Site

Bellflower, California, 90706, United States
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Fullerton, California, 92835, United States
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La Jolla, California, 92093, United States
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Santa Monica, California, 90404, United States
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Santa Rosa, California, 95403, United States
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West Hollywood, California, 90048, United States
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Whittier, California, 90602, United States
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Orlando, Florida, 32804, United States
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Tampa, Florida, 33612, United States
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Kansas City, Kansas, 66160, United States
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Louisville, Kentucky, 40202, United States
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Boston, Massachusetts, 02215, United States
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Henderson, Nevada, 89074, United States
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Albany, New York, 12208, United States
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Canton, Ohio, 44710, United States
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Philadelphia, Pennsylvania, 19104, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Pittsburgh, Pennsylvania, 15232, United States
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Houston, Texas, 77090, United States
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San Antonio, Texas, 78240, United States
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Blacksburg, Virginia, 24060, United States
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Fairfax, Virginia, 22031, United States
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Vancouver, Washington, 98684, United States
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Buenos Aires, C1056ABJ, Argentina
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Buenos Aires, C1125ABD, Argentina
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CABA, C1012AAR, Argentina
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CABA, C1019ABS, Argentina
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Ciudad de Buenos Aires, 1280, Argentina
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Córdoba, 5001, Argentina
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Santa Fe, 2000, Argentina
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Camperdown, 2050, Australia
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Chermside, 4032, Australia
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Elizabeth Vale, 5112, Australia
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Heidelberg, 3084, Australia
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Kogarah, 2217, Australia
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Melbourne, 3000, Australia
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Barretos, 14784-400, Brazil
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Florianópolis, 88034-000, Brazil
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Londrina, 86015-520, Brazil
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Porto Alegre, 91350-200, Brazil
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Ribeirão Preto, 14021-636, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 04029-000, Brazil
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Vitória, 29043-260, Brazil
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Calgary, Alberta, T2N 5G2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Santiago, 7500713, Chile
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Santiago, 8420383, Chile
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Temuco, 4810469, Chile
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Viña del Mar, 2540488, Chile
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Beijing, 100142, China
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Beijing, 100191, China
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Beijing, 100853, China
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Changchun, 130000, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chongqing, 400030, China
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Guangzhou, 510515, China
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Haikou, 570312, China
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Hangzhou, 310003, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Hefei, 230001, China
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Jinan, 250001, China
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Nanjing, 210009, China
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Shanghai, 200030, China
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Shanghai, 200032, China
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Shenyang, 110001, China
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Ürümqi, 830000, China
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Wuhan, 430030, China
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Xi'an, 710061, China
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Zhengzhou, 450008, China
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Olomouc, 775 21, Czechia
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Ostrava - Vitkovice, 703 84, Czechia
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Prague, 140 59, Czechia
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Prague, 150 06, Czechia
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Bordeaux, 33075, France
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Lyon, 69373, France
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Montpellier, 34298, France
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Villejuif, 94805, France
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Belagavi, 590010, India
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Bengaluru, 560027, India
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Gurgaon, 122001, India
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Kolkata, 700160, India
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New Delhi, 110 085, India
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Pune, 411004, India
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Bunkyō City, 113-8431, Japan
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Bunkyō City, 113-8603, Japan
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Fukuoka, 812-8582, Japan
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Hidaka-shi, 350-1298, Japan
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Himeji-shi, 670-8520, Japan
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Iwakuni-shi, 740-8510, Japan
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Kanazawa, 920-8641, Japan
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Kashiwa, 227-8577, Japan
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Kōtoku, 135-8550, Japan
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Osaka, 541-8567, Japan
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Sakaishi, 591-8555, Japan
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Sapporo, 003-0804, Japan
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Sendai, 981-0914, Japan
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Sunto-gun, 411-8777, Japan
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Yokohama, 241-8515, Japan
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Arequipa, AREQUIPA01, Peru
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Lima, 15036, Peru
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Lima, Lima 32, Peru
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Lima, LIMA 34, Peru
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San Isidro, 27, Peru
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Cebu City, 6000, Philippines
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Davao City, 8000, Philippines
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Iloilo City, 5000, Philippines
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Las Piñas, 1740, Philippines
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Legaspi, 4500, Philippines
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Quezon City, 1100, Philippines
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Quezon City, 1112, Philippines
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Moscow, 115478, Russia
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Moscow, 143423, Russia
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Murmansk, 183047, Russia
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Saint Petersburg, 194356, Russia
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Saint Petersburg, 197758, Russia
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Saint Petersburg, 198255, Russia
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Syktyvkar, 167904, Russia
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Bratislava, 82606, Slovakia
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Košice, 041 91, Slovakia
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Poprad, 05801, Slovakia
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Johannesburg, 2196, South Africa
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Port Elizabeth, 6045, South Africa
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Rondebosch, 7700, South Africa
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Cheongju-si, 28644, South Korea
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Goyang-si, 10408, South Korea
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Seoul, 03080, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Changhua, 500, Taiwan
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Hualien City, 97002, Taiwan
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Kaohsiung City, 00807, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 23561, Taiwan
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Bangkok, 10210, Thailand
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Hat Yai, 90110, Thailand
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Khon Kaen, 40002, Thailand
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Muang, 50200, Thailand
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Cambridge, CB2 0QQ, United Kingdom
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Leicester, LE1 5WW, United Kingdom
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Liverpool, L7 8YA, United Kingdom
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Maidstone, ME16 9QQ, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 70000, Vietnam

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